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

Model Number 195-100

Device Problem Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2021

Event Type  malfunction  

Event Description

Abbott binaxnow covid-19 ag card home test received tests from abbott on 9/21/2021 - they were supplied foc due to a previous invalid test.I have (b)(6) tracking to confirm date if needed.Took tests on trip to (b)(6).Signed onto emed (b)(6) 2021 to do test.As part of that process you remove an outer card sleeve and the proctor scans a qr code to validate the test type/information.I was informed test was out of date.I had two additional tests - we checked both - all were out of date.Expiry date on tests was 9/18/2021 my concerns are: tests were delivered on 9/21/2021 and exp date was 9/18/2021; date does not have the wording 'expiry or exp date' next to it.If says 'ref' which could mean anything; date is covered up by cardboard sleeve which very clearly states 'do not remove' making it impossible for a consumer to read the expiry date prior to actual usage; main purpose of test is to take abroad with you to carry out pre-return to the usa.It is proactively marketed by (b)(6), (b)(6) etc; as of 12/28/2021 tests have to be taken on the day prior to flying and therefore it is in a situation like this impossible to then source/request an alternative test.While that may not be a medical side-effect concern to the fda it is a practical one given the purpose of the product.I have taken images of the test batch numbers and packaging if required.Fda safety report id# (b)(4).

• Brand Name: ABBOTT BINAXNOW COVID-19 AG CARD HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 13117891
• MDR Text Key: 283153968
• Report Number: MW5106352
• 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: 12/28/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/18/2021
• Device Model Number: 195-100
• Device Lot Number: 139380
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White