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 1 - Foreign malfunction relevant for US combination product

Scenario. The Combination Product Applicant markets an NDA-approved (NDA 123456) prefilled syringe with integrated needle safety device. The Applicant also markets a combination product outside the US that includes a different drug and the same device. The US product contains drug product, Drug A, which contains the active ingredient, Active A. The foreign product contains drug product, Drug O, which contains the active ingredient, Active O, which is not marketed in the US. Both products contain syringe with integrated needle safety device, SafeSyringe1.

The Combination Product Applicant receives a report for the foreign product that only involves a malfunction that is assumed to be reportable for purposes of this scenario if it were to occur on NDA 123456 (21 CFR 4.102(c) and 803.50). The malfunction was reported by a nurse at XYZ Hospital and involved premature deployment of the needle safety device.

Data Elements.  NDA123445 is identified using the “5-similar device” drug characterization and malfunction equals “yes” because the event, if it occurred on the US combination product, would be reportable.

The Combination Product Applicant searches the Device Product Classification Database and identifies product code MEG for “Syringe, Antistick.”

The Combination Product Applicant reviews the Device Problem Codes and identifies Premature Activation FDA 1484 “Problem associated with early and unexpected activation of the device” 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 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	<fulfillexpeditecriteria>	5 = 30-Day
Popatient Identifier	B.1.1	<patientinitial>	NONE
Reporter Identifier	A.2.1.2a	<reporterorganization>	XYZ General Hospital
	A.2.1.4	<qualification>	3 = Other Health Professional
Suspect Drug Product	B.4.k.1	<drugcharacterization>	5=Similar Device
	B.4.k.2.1	<medicinalproduct>	Drug A
	B.4.k.2.2	<activesubstancename>	Active A
	B.4.k.4.1	<drugauthorizationnumb>	NDA 123456
Suspect Medical Device and Device Problem Code	B.4.k.20.FDA.1	<brandname>	SafeSyringe1
	B.4.k.20.FDA.2	<commondevicename>	Syringe, Antistick
	B.4.k.20.FDA.3	<productcode>	MEG
	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>	1484
Adverse Event Coding	B.2.i.0	<primarysourcereaction>	No Adverse Event

 

Scenario 2 - US malfunction for one combination product that could occur in another US-marketed combination product

Scenario. The Combination Product Applicant markets two NDA-approved combination products, NDA1 and NDA2, that contain different drug products, but use the same autoinjector device constituent part. NDA1 contains drug B and active B. NDA2 contains drug C and active C.

The Combination Product Applicant receives a report for NDA1 that involves only a reportable malfunction. For purposes of this scenario, it is assumed that the malfunction would also be reportable if it were to occur on NDA2 (21 CFR 4.102(c) and 803.50). The malfunction was reported by a nurse at XYZ Hospital and involved failure to deliver a dose when the autoinjector was activated.

Data Elements.

The event occurred on NDA1, which is identified as “1=Suspect” in the report. Because NDA2 has a similar device for which the malfunction would be reportable if it recurred on the NDA2 product, NDA2 is identified using the “5=Similar device” drug characterization. Malfunction equals “yes” for both because the malfunction that occurred is reportable for both products.

The Combination Product Applicant searches the Device Product Classification Database and identifies product code KZY for “Introducer, Syringe Needle.”

The Combination Product Applicant reviews the Device Problem Codes and identifies Failure to Deliver FDA 2338 “Failure (=complete nonperformance) with regard to the intended function of the device.”

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 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	<fulfillexpeditecriteria>	5 = 30-day
Patient Identifier	B.1.1	<patientinitial>	NONE
Reporter Identifier	A.2.1.2a	<reporterorganization>	XYZ General Hospital
	A.2.1.4	<qualification>	3 = Other Health Professional
Suspect Drug Product	B.4.k.1	<drugcharacterization>	1=Suspect
	B.4.k.2.1	<medicinalproduct>	Drug B
	B.4.k.2.2	<activesubstancename>	Active B
	B.4.k.4.1	<drugauthorizationnumb>	NDA1
Suspect Medical Device and Device Problem Code	B.4.k.20.FDA.2	<commondevicename>	Autoinjector
	B.4.k.20.FDA.3	<productcode>	KZH
	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>	1484
Suspect Drug Product	B.4.k.1	<drugcharacterization>	5=Similar Device
	B.4.k.2.1	<medicinalproduct>	Drug C
	B.4.k.2.2	<activesubstancename>	Active C
	B.4.k.4.1	<drugauthorizationnumb>	NDA2
Suspect Medical Device and Device Problem Code	B.4.k.20.FDA.1	<commondevicename>	Autoinjector
	B.4.k.20.FDA.2	<productcode>	KZH
	B.4.k.20.FDA.3	<malfunction>	1=Yes
	B.4.k.20.FDA.17	<evaluation type>	01 = Device Problem
	B.4.k.18.6.FDA.19.1a	<evaluationvalue>	1484