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FAERS Example Scenario. NDA-approved prefilled on-body infusor

FAERS Example Scenario. NDA-approved prefilled on-body infusor

The following scenario is intended solely to illustrate how to provide combination product information identified in section V.B.2 of the Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff in the data fields of the FAERS reporting system. The scenario described below is not intended to provide a comprehensive representation of all information that may be appropriate to include in ICSRs or how to present it, for a given event, report type, or product type, nor to identify all reports that may be required in relation to the events described.

Scenario. The Combination Product Applicant for an NDA-approved (NDA 123456) prefilled on-body infusor receives information on an event that only involved a reportable malfunction (see 21 CFR 4.102(c) and 803.50). The malfunction was reported by a nurse at XYZ General Hospital and involved a software problem where a dose was missed because the on-body infusor indicated that a dose had been administered when, in fact, no dose was administered. The on-body infusor is prefilled with the drug product, Drug A, which contains the active ingredient, Active A. The infusor is branded as Infusor A. 

Data Elements. The Combination Product Applicant searches the Device Product Classification Database, but does not find any product codes that align with the on-body infusor and therefore does not include the procode but does provide a device common name.

The Combination Product Applicant reviews the Device Problem Codes and identifies “Medication Error FDA 3198; C91396 Event in which the device software design results in errors of medication preparation or administration” as appropriate for the malfunction. 

Because this was a malfunction-only event, there was no adverse patient reaction. Therefore, the Combination Product Applicant does not identify an adverse patient reaction and uses “None” for patient identifier and “No Adverse Event”  in the adverse event coding.

In addition to other appropriate content for the Malfunction report type, the Combination Product Applicant completes the following elements in the ICSR data fields for FAERS as indicated below:

Type of Information
(see section V.B.2 of the PMSR guidance)
Data Element DTD Descriptor Element Value
Combination Product Report Identifier A.1.FDA.15 <combinationproductreport> 1 = Yes
Report Type(s) A.1.9   A.1.9 <fulfillexpeditecriteria> 5 = 30-Day
B.4.k.20.FDA.17 <malfunction>  1 = Yes
Patient Identifier B.1.1 <patientinitial> None
Reporter Identifier 1 A.2.1.2a  <reporterorganization>   XYZ General Hospital
A.2.1.4 <qualification> 3 = Other Health Professional
Suspect Medical Device and Device Problem Code B.4.k.20.FDA.1 <brandname> Infusor A
B.4.k.20.FDA.2 <commondevicename> On-body Infusor
B.4.k.20.FDA.3 <productcode>  [blank]
B.4.k.20.FDA.17   <malfunction>  1 = Yes
B.4.k.18.6.FDA.19.1a <evaluation type> 01 = Device Problem
B.4.k.18.6.FDA.19.1b <evaluationvalue>  3198
Suspect Drug Product  B.4.k.2.1 <medicinalproduct> Drug A
B.4.k.2.2 <activesubstancename> Active A
B.4.k.4.1 <drugauthorizationnumb>  NDA 123456
Adverse Event Coding B.2.i.0  <primarysourcereaction> No Adverse Event










 


1 Identify the reporter using the following data element(s) as applicable and known:  Reporter title (A.2.1.1a <reportertitle>), Reporter given name (A.2.1.1b <reportergivename>), Reporter middle name (A.2.1.1c <reportermiddlename>), Reporter family name (A.2.1.1d <reporterfamilyname>), Reporter organization (A.2.1.2a <reporterorganization>), Reporter department (A.2.1.2b <reporterdepartment>), Reporter street (A.2.1.2c <reporterstreet>), Reporter city (A.2.1.2d <reportercity>), Reporter state or province (A.2.1.2e <reporterstate>), Reporter postcode (A.2.1.2f <reporterpostcode>), Reporter country code (A.2.1.3 <reportercountry>).