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  1. MDR Adverse Event Codes

This page gives an overview of how reporters should use the MDR adverse event codes when filling out the MedWatch 3500A form.

General Instructions

In general, reporters are expected to provide at least one code for each adverse event code field that is relevant to their MDR. Note that this applies only to mandatory MDR reporting, which uses the 3500A form.

When prompted, reporters should select the lowest level, most detailed code or codes necessary to describe the event. Each parent code in the hierarchy is considered to be a set containing all of its child codes, so there is no need to choose both a parent and one of its children – the child code alone is sufficient. Depending on the submission method, the mechanics of how the reporter will choose the code will be different. For more information, see the Submission Methods section below.

There are two distinct coding scenarios; one is for manufacturers, and the other is for importers and user facilities. Depending on the type of reporter, the section of the 3500A where codes are entered and the code types required will be different.

Importers and User Facilities (F10)

Importers (or distributors) and user facilities are required to complete section F of the 3500A form, which includes event problem codes in section F10. F10 prompts the reporter to specify a device problem code and a patient problem code. For section F10 to be complete, reporters must select at least one device problem code and one patient problem code.

When entering the patient problem code, reporters should select the lowest-level (i.e. most detailed) code or codes that describe what happened to the patient as a result of the event. Note that the root-level parent code of this set (Patient Problem/Medical Problem) will not be accepted as a valid code, as it is a generic parent code for all patient problem codes.

When entering the device problem code, reporters should select the lowest-level (i.e. most detailed) code or codes that most accurately describe the device failures or problems observed during the event.

For some events, including a device component code (indicating which device component or assembly was involved) may provide more insight into the device problem observed. Reporters may enter a device component code in the device problem code field, in addition to the device problem code; however, they are not required to do so. If the reporter chooses to do so, they should select one or more codes that most accurately describe the component associated with the device problem encountered during the event. Note that the root-level parent code of this set (Device Component or Accessory) will not be accepted as a valid code, as it is a generic parent code for all device component codes. Also, note that the inclusion of a device component code is not sufficient to complete section F10 in the absence of a device problem code.

Manufacturers (H6)

Manufacturers are required to complete section H of the 3500A form, which includes adverse event codes in section H6. H6 prompts the reporter to specify a device problem code, patient problem code, manufacturer evaluation method code, manufacturer evaluation result code, and manufacturer evaluation conclusion code. For section H6 to be complete, reporters must select at least one of each of these five code types.

For the device problem code and patient problem code fields, please refer to the instructions above for importers and user facilities. Although the fields are located in section H6 for manufacturers, the same instructions apply for selecting each code.

When entering the manufacturer evaluation method code, reporters should select the lowest-level (i.e. most detailed) code or codes that most accurately describe the method of investigation of the device involved in the reported event.

When entering the manufacturer evaluation result code, reporters should select the lowest-level (i.e. most detailed) code or codes that most accurately describe the specific findings from the investigation of the device involved in the reported event.

For some events, including a device component code (indicating which device component or assembly was involved) may provide more insight into the evaluation result found. Reporters may enter a device component code in the manufacturer evaluation result code field, in addition to the evaluation result code; however, they are not required to do so. If the reporter chooses to do so, they should select one or more codes that most accurately describe the component associated with the evaluation result specified. Note that the root-level parent code of this set (Device Component or Accessory) will not be accepted as a valid code, as it is a generic parent code for all device component codes. Also, note that the inclusion of a device component code is not sufficient to complete section H6 in the absence of an evaluation result code.

When entering the manufacturer evaluation conclusion code, reporters should select the lowest-level (i.e. most detailed) code or codes that describe the conclusions from the investigation of the device involved in the reported event.

Submission methods

The mechanics of selecting and entering the adverse event codes in an MDR depend upon the submission method used by the reporter. Although two reporters may be the same type of entity (e.g. both manufacturers), the process of reporting differs depending on the submission method. This section will outline the process of entering adverse event codes for each possible submission method.

Paper

The eMDR Rule mandates that manufacturers and importers (or distributors) submit their MDRs electronically via eMDR; however, user facilities are still able to submit 3500A paper reports to CDRH.

When filling out section F10, paper reporters should refer to the Device Problem Code hierarchy and the Patient Problem Code hierarchy files, which are available on the Coding Resources page. Reporters should browse each hierarchy and choose the most appropriate code or codes before writing them into the corresponding boxes on the form. When entering the codes, reporters should write only the 2 to 4 digit FDA code number in each box.

The 3500A form has space for three device problem codes and three patient problem codes in section F10. If reporters would like to provide more than 3 codes, they may record additional codes by writing “F10:” followed by the additional codes in the H10 block.

eSubmitter

Electronic reporters using eSubmitter to generate MDRs will be prompted to enter adverse event codes once they reach the appropriate section in the 3500A wizard. For each code type, reporters should follow these steps:

  1. Click the + button below the name of the code type. A dialog will appear.
  2. If you know the FDA code number for the code that you wish to use, please enter it in the code box at the top left. Then skip to step 4 below.
  3. If you do not know an exact FDA code number, please enter a descriptive term in the code name box at the top right.
  4. In the area below the code and code number boxes, a section of the hierarchy will be displayed. The hierarchy will contain one or more codes that match the number or term that was entered, as well as their related codes. Highlight one of these codes and click the Select button at the bottom left to add the code to the list of currently selected codes.
  5. If you would like to add more codes of this type, repeat the process from steps 2 through 4.
  6. When you are finished adding codes, click the OK button at the bottom right to return to the main eSubmitter screen.

Once finished entering adverse event codes for all required code types, reporters may continue to the next section in the eSubmitter 3500A wizard.

AS2 XML

Electronic reporters using the ESG AS2 gateway to submit to eMDR must maintain a custom software solution for reporting. A firm's reporting system must be able to generate submission XML files that adhere to the HL7 ICSR schema. For detailed information on how to create the XML submission file for eMDR, as well as where and how to include the appropriate adverse event codes, please download the eMDR Implementation Package.

AS2 reporters should note that their HL7 XML custom software may indicate an adverse event code using the FDA code or the NCIt code associated with it. More information on how to include NCIt codes in the XML is included in the eMDR implementation package.