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

Device Problems Product Quality Problem (1506); Component Missing (2306); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2021

Event Type  malfunction  

Event 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
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 13141613
• MDR Text Key: 283154164
• Report Number: MW5106394
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: (01)00811877011330
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White