MAUDE Adverse Event Report: ABBOTT BINAXNOW COVID-19 AG CARD HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number	BINAXNOW COVID-19 AG CARD HOME T
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Abbott "binaxnow covid-19 ag card home test", lot 1413200, delivered with empty reagent bottle: "covid-19ag card extraction reagent", lot#: g0126470 / exp.10/01/2021.Test kit failed to perform desired test due to empty reagent bottle.Emed was proctoring the test and witnessed the failure.Matter reported to abbott: case (b)(6) matter reported to emed: ticket number: (b)(6), requested replacement kit, but none has been delivered nor scheduled.Kit failed to perform test.Fda safety report id# (b)(4).

• Brand Name: BINAXNOW COVID-19 AG CARD HOME TEST
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 13141613
• Report Number: MW5106394
• Device Sequence Number: 19710617
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: (01)00811877011330
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/28/2021
• Device Model Number: BINAXNOW COVID-19 AG CARD HOME T
• Device Catalogue Number: BINAXNOW COVID-19 AG CARD HOME
• Device Lot Number: 141320
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2021
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White