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U.S. Department of Health and Human Services

Medical Devices

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Submitting Event Problem Codes

Submitters are able to use one of the following methods of Medical Device Report Submission to submit event problem codes:

Additionally, there are some cases when an appropriate code cannot be found:

Paper version of 3500A Form

Please use the following instructions for entering each of the three CDRH Event Problem Codes on the paper MedWatch 3500A form:

Note: Only use FDA codes for paper submissions

Patient Problem Code

1. Select the lowest-level (i.e. most detailed) code(s) from the code list that describes what happened to the patient as a result of the event. The topmost level of the hierarchy will not be accepted as a valid code. See Patient Problem Code resource files to aid in patient problem code selection:

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • CDRH Patient Problem Codes Disposition - An Excel file that lists all the FDA CDRH Patient Problem Codes and terms (organized alphabetically) and maps to the improved Patient Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the improved term, known as the "Preferred Term". The file also indicates which terms were inactivated or newly created as part of this project.
  • Patient Problem Code Hierarchy – organizes the patient problem codes as a hierarchical listing

2. Enter the 4-digit FDA Code number in section F10 in the box labeled “Patient”. Select as many Patient Problem Codes as appropriate. The 3500A form allows entry of 3 codes in Section F10. Feel free to record additional codes on a separate sheet, mark it "F10", and provide the report number and page number, or by inserting additional codes in the H10. Block on the 3500A form.

Device Problem Code

1. Select the lowest-level (i.e. most detailed) code(s) from the Device Problem Code Hierarchy that most accurately describes the device failures or problems encountered during the event. Codes at the topmost level of the hierarchy will not be accepted. See Device Problem Code resource files to aid in device problem code selection:

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • CDRH Device Problem Codes Disposition – An Excel file that lists all the FDA CDRH Device Problem Codes and terms (organized alphabetically) and maps to the improved Device Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the Preferred Term. The file also indicates which terms were inactivated as part of this project.
  • Device Problem Code Hierarchy – organizes the device problem codes as a hierarchical listing

2. Codes are not shown for higher level terms because FDA will not accept reporting at the highest level of the hierarchy. Device Problem Codes must be selected from Level 2, Level 3, Level 4, Level 5 or Level 6 of the Device Problem Code Hierarchy. Codes from Level 1 of the Device Problem Code Hierarchy are not allowable codes for entry into the FDA 3500A form. These higher-level codes are provided to aid in understanding the context for coding the Device Event, but are too general to be useful for coding an adverse event.

3. Enter the 4-digit FDA Code number in section F10 in the box labeled “Device”. Select as many Device Problem and Component Codes as appropriate. The 3500A form allows entry of 3 codes in Section F10. Feel free to record additional codes on a separate sheet, mark it "F10", and provide the report number and page number. There are no requirements for indicating or tracking the level of the Hierarchy selected.

4. If a particular component can be associated with the Device Problem, enter the 3 or 4 digit FDA Component Code in the box labeled ‘device’. See section 2.1.3 below.

In order for Field F10 to be complete, you must select at least one patient problem code and one device problem code.

For malfunction reports only:
Use FDA code 2199: no consequences or impact to patient to describe reportable malfunctions involving a patient who sustained no adverse outcomes.
Use FDA code 2645: no patient involvement to describe reportable malfunctions not involving a patient.

Component Code (Optional)

1. Select the lowest-level (i.e. most detailed) code(s) from the Component list that most accurately describes the component associated with the Device Problems encountered during the event. See Component Code resource files:

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Component Code Hierarchy - organizes the component codes as a hierarchical listing.
  • Component Code Disposition File – CDRH has updated the list of components used in medical device reporting (MDR). These components can be found as new Component Codes for entry on MedWatch Form 3500A, Field F.10. and as updates to the 'component' section of the H.6. Manufacturer Evaluation Results Codes. Note: the component codes listed in each of these sections are now exactly the same and can be used to report component information in either F.10. or H.6. of the MedWatch 3500A Form. To see what has changed, please see the Component disposition file which includes FDA code # changes, new codes, as well as inactivated codes.

2. Component Codes are not required, but can be used to further describe a Device Problem selected in the Device Problem Code. NOTE: Do not submit a component Code without a Device Problem Code.

3. Enter the 3 or 4-digit FDA Code number in section F10 in the box labeled “Device”. Enter up to 3 codes from the Device Problem and Component Code Hierarchy. Select as many Device Problem and Component Codes as appropriate. The 3500A form allows entry of 3 codes in Section F10. Feel free to record additional codes on a separate sheet, mark it "F10", and provide the report number and page number.

Please note: there are 25 component codes that have updated code numbers. See below for the new FDA Code assigned to these 25 component code terms.

 Component Term  C-code  Old FDA Code NEW
FDA CODE
KNIFEC540211029 3156
PusherC540231031 3157
SWITCH, PUSH BUTTONC540131024 3154
ThermometerC500591001 3158
ThermostatC502211002 3159
ThyristorC502221003 3135
TimerC502231004 3136
TrackballC502241005 3137
TransceiverC502251006 3138
TranslatorC502291007 3139
Transmission lineC502301008 3140
TransmitterC502311009 3141
TransponderC502321010 3142
TransportC502331011 3143
TRIACC502341012 3144
TrimmerC502351013 3145
TunerC502401014 3146
VALVE CAMC540161025 3155
VaristorC502631015 3147
VibratorC502651016 3148
ViewerC502661017 3149
WasherC502671019 3150
WaveguideC499761020 3151
WindowC502681021 3152
YokeC502731022 3153

Electronic submission using HL7 ICSR

Please use the following instructions for entering each of the three CDRH Event Problem Codes using the HL7 ICSR messaging format:

Patient Problem Code

1. Select the lowest-level (i.e. most detailed) code(s) from the code list that describe what happened to the patient as a result of the event. See Patient Problem Code resource files to view or download the Patient Problem Codes, Problem Code definitions, and files showing a mapping between current and enhanced codes.

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Patient Problem Codes Disposition – An Excel file that lists all the FDA CDRH Patient Problem Codes and terms (organized alphabetically) and maps to the improved Patient Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the improved term, known as the "Preferred Term". The file also indicates which terms were inactivated or newly created as part of this project.
  • Patient Problem Code Hierarchy – organizes the patient problem codes as a hierarchical listing

2. Until further notice, electronic submitters may choose to submit Event Problem Codes using either the FDA or C-codes. Eventually the C-codes will replace the current FDA-assigned code to facilitate Event Problem Code adoption as device problem terminology by a variety of organizations.

3. Use HL7 ICSR messaging format to transmit the selected codes. Below is the original HL7 ICSR coding to represent selection of Patient Problem Code FDA 2132; C50802 – ventricular tachycardia:

- <subjectOf>
- <observation moodCode="EVN">
- <!-- Event Problem Codes\Patient Problem Codes, BOX F10 -->
- <!-- for multiple values, repeat subjectOf block -->
- <!-- Use NCI concept code to indicate the concept -->
- <!-- Value is populated with valid MAUDE Patient Problem Code such as Aneurysm -->
- <!-- use FDA OID for codeSystem in value -->
<observation>
<code code="C53983" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="Patient_Problem_Code" />
<value xsi:type="CE" code="2132" codeSystem="2.16.840.1.113883.3.24" />
</observation>
</subjectOf>

The following shows the changes required to represent selection in the enhanced coding system. Specifically, the 4-digit FDA code 2132 for ventricular tachycardia will be replaced with the associated NCI code – C50802 and the codesystem name will change from FDA (2.16.840.1.113883.3.24) to NCI (2.16.840.1.113883.3.26.1.1)

- <subjectOf>
- <observation moodCode="EVN">
- <!-- Event Problem Codes\Patient Problem Codes, BOX F10 -->
- <!-- for multiple values, repeat subjectOf block -->
- <!-- Use NCI concept code to indicate the concept -->
- <!-- Value is populated with valid MAUDE Patient Problem Code such as Aneurysm -->
- <!-- use NCI OID for codeSystem in value -->
<observation>
<code code="C53983" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="Patient_Problem_Code" />
<value xsi:type="CE" code="C50802" codeSystem="2.16.840.1.113883.3.26.1.1" />
</observation>
- </subjectOf>

4. Repeat the above segment of code for all selected codes. There is no upper limit to the number of CDRH Event Problem Codes that can be assigned.

Device Problem Code

1. Select the lowest-level (i.e. most detailed) code(s) from the Device Problem Code Hierarchy that most accurately describes the device failures or problems encountered during the event. See Problem Code resource files to view or download the Device Problem Code Hierarchy, Problem Code definitions, and files showing a mapping between current and enhanced codes.

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Device Problem Code Disposition File – An Excel file that lists all the FDA CDRH Device Problem Codes and terms (organized alphabetically) and maps to the improved Device Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the Preferred Term. The file also indicates which terms were inactivated as part of this project.
  • Device Problem Code Hierarchy - organizes the device problem codes as a hierarchical listing

2. Device Problem Codes must be selected from Level 2, Level 3, Level 4, Level 5 or Level 6 of the Device Problem Code Hierarchy. Until further notice, electronic submitters may choose to submit Event Problem Codes using either the FDA or C-codes. Eventually the C-codes will replace the current FDA-assigned code to facilitate Event Problem Code adoption as device problem terminology by a variety of organizations. Note: Problem Codes from Level 1 of the Device Problem Code Hierarchy are not allowed values. These higher-level codes are provided to aid in understanding the context for coding the Device Problem, but are too general to be used to code an adverse event. There are no requirements for indicating or tracking the level of the Hierarchy selected.

3. Use HL7 ICSR messaging format to transmit the selected codes. Below is the original HL7 ICSR coding to represent selection of Device Problem Codes FDA 1449; C63083 – Parameter calculation error due to software problem and FDA 1457; C62876 – paravalvular leak(s):

<subjectOf>
- <!-- Event Problem Codes\Device Code, BOX F10 -->
- <!-- for multiple values, repeat subjectOf block -->
- <!-- Use NCI concept code to indicate the concept -->
- <!-- use FDA OID for codeSystem in value -->
- <!-- Value populated with valid MAUDE Device Problem Code such as 1449 parameter calculation error due to software problem and 1457 paravalvular leak -->
<deviceObservation>
<code code="C53982" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="Device_Problem_Code" />
<value xsi:type="CE" code="1457" codeSystem="2.16.840.1.113883.3.24" />
</deviceObservation>
</subjectOf>

The following shows the changes required to represent selection in the enhanced coding system. Specifically, the 4-digit FDA code 1457 for paravalvular leak will be replaced with the associated NCI code - C62876 - code and the codesystem name will change from FDA (2.16.840.1.113883.3.24) to NCI (2.16.840.1.113883.3.26.1.1)

<subjectOf>
- <!-- Event Problem Codes\Device Code, BOX F10 -->
- <!-- for multiple values, repeat subjectOf block -->
- <!-- Use NCI concept code to indicate the concept -->
- <!-- use NCI OID for codeSystem in value -->
- <!-- Value populated with the enhanced NCI Device Problem Code, C62876 -->
<deviceObservation>
<code code="C53982" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="Device_Problem_Code" />
<value xsi:type="CE" code="C62876" codeSystem="2.16.840.1.113883.3.26.1.1" />
</deviceObservation>
</subjectOf>

4. Repeat the above segment of code for all selected codes. There is no upper limit to the number of CDRH Event Problem Codes that can be assigned.

In order for Field F10 to be complete, you must select at least one patient problem code and one device problem code.

For malfunction reports only:
Use C-Code C50675; FDA code 2199: no consequences or impact to patient to describe reportable malfunctions involving a patient who sustained no adverse outcomes.
Use C-Code C50912; FDA code 2645: no patient involvement to describe reportable malfunctions not involving a patient.

Component Code (Optional)

1. Select the lowest-level (i.e. most detailed) code(s) from the Component list that most accurately describes the component associated with the Device Problem encountered during the event. See Problem Code resource files to view or download the Component list.

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Component Code Hierarchy – organizes the component codes as a hierarchical listing
  • Component Code Disposition File – CDRH has updated the list of components used in medical device reporting (MDR). These components can be found as new Component Codes for entry on MedWatch Form 3500A, Field F.10. and as updates to the 'component' section of the H.6. Manufacturer Evaluation Results Codes. Note: the component codes listed in each of these sections are now exactly the same and can be used to report component information in either F.10. or H.6. of the MedWatch 3500A Form. To see what has changed, please see the Component disposition file which includes FDA code # changes, new codes, as well as inactivated codes.

2. Component Codes are not required, but can be used to further describe a Device Problem. A Component Code cannot be submitted without a Device Problem Code. To see an example, please refer to CDRH Event Problem Code Case Studies in this document and online available at the Event Problem Codes Website.
Use the same XML HL7 ICSR segment as used for the Device Problem Code. Future releases of the HL7 ICSR will have a separate tag for component, but this is not currently available. See example for coding Electrical Lead – FDA 452; C50027.

<subjectOf>
<deviceObservation>
<code code="C53982" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="Device_Problem_Code" />
<value xsi:type="CE" code="C50027" codeSystem="2.16.840.1.113883.3.26.1.1" />
</deviceObservation
</subjectOf>

For further details about the HL7 ICSR and for submitting all vocabulary items using HL7 ICSR, please refer to the CDRH Electronic Reporting website.

eSubmitter

Please use the following instructions for entering each of the three CDRH Event Problem Codes using eSubmitter application:

Note: These instructions may change as additional details become available.

Patient Problem Code

1. Select the lowest-level (i.e. most detailed) code(s) from the code list that describes what happened to the patient as a result of the event. On the Patient Problem Code Filter Dialog screen, enter a term into the search field to pull all relevant codes. The system should return possible patient codes for selection. Select the most appropriate code. (Note: If you need further assistance in selecting a code, s ee Problem Code resource files to view or download the Patient Problem Codes, Problem Code definitions, and files showing a mapping between current and enhanced codes.)

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Patient Problem Code Disposition File - An Excel file that lists all the FDA CDRH Patient Problem Codes and terms (organized alphabetically) and maps to the improved Patient Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the improved term, known as the "Preferred Term . The file also indicates which terms were inactivated or newly created as part of this project.
  • Patient Problem Code Hierarchy - organizes the patient problem codes as a hierarchical listing

If you are still unable to assign a Patient Problem Code, select code ‘No code available’ and enter a description of the problem in the associated text field.

2. If you wish to add more Patient Problem Codes, repeat step 1.

3. The system will store your code selection(s) and your information will be transmitted electronically via an HL7 ICSR message.

Device Problem Code

1. Select the lowest-level (i.e. most detailed) code(s) from the Device Problem Code Hierarchy that most accurately describes the device failures or problems encountered during the event.

2. On the Device Problem Code Filter Dialog screen, use the search or browse function to select the appropriate code. Enter a term into the search field to pull up all relevant codes,

3. Select ‘details’ for a desired code. The Details screen will list the parent and children of the selected code as well as definitions and synonyms. Use this information to determine code selection. If you are still unable to assign a Device Problem Code, select See Problem Code resource files to view or download the Device Problem Code Hierarchy, Problem Code definitions, and files showing a mapping between current and enhanced codes.

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Device Problem Code Disposition File - An Excel file that lists all the FDA CDRH Device Problem Codes and terms (organized alphabetically) and maps to the improved Device Problem Codes. The file shows exactly what happened to each code and provides recommendations for selection of the Preferred Term. The file also indicates which terms were inactivated as part of this project.
  • Device Problem Code Hierarchy - organizes the device problem codes as a hierarchical listing

If you are still unable to assign a Device Problem Code, select code ‘No code available’ then enter a description of the problem in the associated text field.

4. Device Problem Codes must be selected from Level 2, Level 3, Level 4, Level 5 or Level 6 of the Device Problem Code Hierarchy. The ceSub application will not allow you to select Device Problem Codes from Level 1 of the Device Problem Code Hierarchy. These higher-level codes are provided to aid in understanding the context for coding the Device Problem, but are too general to be used to code an adverse event.

5. If you wish to add more Device Problem Codes, select ‘Add another code’ and repeat steps 1-4.

6. The system will store your code selection(s).

7. If a particular component can be associated with the Device Problem, see the Component coding instructions below.

In order for Field F10 to be complete, you must select at least one patient problem code and one device problem code.

For malfunction reports only:
Use C-Code C50675; FDA code 2199: no consequences or impact to patient to describe reportable malfunctions involving a patient who sustained no adverse outcomes.
Use C-Code C50912; FDA code 2645: no patient involvement to describe reportable malfunctions not involving a patient.

Component Code (Optional)

Component Codes are not required, but can be used to further describe a Device Problem selected in the Device Problem Code. A Component Code cannot be submitted without a Device Problem Code.

1. Select the lowest-level (i.e. most detailed) code(s) from the Component list that most accurately describes the component associated with the Device Problems encountered during the event. On the Component screen, use the search or browse function to select the appropriate code. Enter a term into the search field, to pull up relevant codes. The system will return possible codes for selection. Select the most appropriate code. (Note: If you need further assistance in selecting a code, see Problem Code resource files to view or download the component codes, Problem Code definitions, and files showing a mapping between current and enhanced codes.)

  • CDRH has developed the Event Problem Code terminology for reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel and Text formats for importing into other applications.
  • Component Code Hierarchy - organizes the component codes as a hierarchical listing
  • Component Code Disposition File – CDRH has updated the list of components used in medical device reporting (MDR). These components can be found as new Component Codes for entry on MedWatch Form 3500A, Field F.10. and as updates to the 'component' section of the H.6. Manufacturer Evaluation Results Codes. Note: the component codes listed in each of these sections are now exactly the same and can be used to report component information in either F.10. or H.6. of the MedWatch 3500A Form. To see what has changed, please see the Component disposition file which includes FDA code # changes, new codes, as well as inactivated codes.

2. If you wish to add more Component Codes, select ‘Add another code’ and repeat steps 1. There is no limit to the number of Component Codes that can be selected.

3. The system will store your code selection(s) and your information will be transmitted electronically via an HL7 ICSR message.

For Further details about the eSubmitter application and for submitting adverse event reports using that electronic option, please refer to the FDA eSubmitter.

When a Code cannot be selected

FDA CDRH strongly encourages the selection of an available code from the Patient and Device Problem Codes. However, we are aware that there are unusual circumstances when a code cannot be selected. These codes are categorized under the parent, “Missing Value Reason” meaning there is no meaningful code that best captures the event. Please see below table for instructions:

Code Description NCI C–code Number FDA Code Number Use When…
Missing Value Reason Cannot code at this levelCannot code at this levelDo not use. Missing Value Reason is a parent term for all null flavor codes.
Not Applicable C486603189A code is not applicable for this field. There may not be an appropriate code to capture the adverse event. CDRH recommends completing a Code Request Form and submitting to CDRH to ensure that an appropriate code is available. For more details about a coding request, see Requesting a New Code.
No Information C532693190No information is available for this field. There is not enough information about the adverse event to assign a Patient and/or Device Problem. An example would be if no information was given about the patient outcome or there was no patient involved.
No Code Available C643433191Information is available to code the component, Device Problem, or Patient Problem, but an appropriate code does not exist. CDRH recommends completing a Code Request Form and submitting to CDRH to ensure that an appropriate code is available. For more details about a coding request, see Requesting a New Code.
No Known Device ProblemC76126Used when coding for Device Problems only: FDA 2993A device issue may be associated with the adverse event outcome; this association is not known at time of report submission.
No Known Impact or Consequence to PatientC76143Used when coding for Patient Problems only: FDA 2692Patient impact or consequence in a reported event is not known at time of report submission, or there is no patient involvement in association with reported event.