MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX COVID 19 ANTIGEN HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number	L031-118B5
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
I believe false positives are occuring with the flowflex antigen test.Lot:# cov1110226, exp 11-28-2022.These were provided to me by my place of employment, minneapolis public schools.I first tested positive with them (b)(6) 2022, had minimal symptoms (slight runny nose, but i had just traveled by air across the country so easily could've been pollen, using n95 on plane for 5 hours, etc).I really became suspicious when i once again tested positive a month later, same batch of tests on (b)(6) 2023.I followed it immediately with a binax test which was negative.I repeated on monday: flowflex was positive; binax was negative.I then went for a pcr(polymerase chain reaction) on monday (b)(6) 2023, which just came back with negative results.I don't know how to explain it other than the flowflex are false positives.I am a school nurse and these are the tests we give out to families.If these tests are bad, we need to know.I've tried to research if this is happening with other flowflex tests, but only have seen the recall of the dark blue box, which this is not.

• Brand Name: FLOWFLEX COVID 19 ANTIGEN HOME TEST
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 16363159
• Report Number: MW5114868
• Device Sequence Number: 18148476
• Product Code: QKP
• UDI-Device Identifier: 00682607660261
• UDI-Public: (01)00682607660261
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/08/2023
• 2 Devices were Involved in the Event: 1 2

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: 11/28/2022
• Device Model Number: L031-118B5
• Device Catalogue Number: 660261
• Device Lot Number: COV1110226
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2023
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White