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

Model Number L031-118B5

Device Problems False Positive Result (1227); Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2023

Event Type  malfunction  

Event 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
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 16363159
• MDR Text Key: 309479207
• Report Number: MW5114868
• Device Sequence Number: 2
• Product Code: QKP
• 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: 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
• Device Expiration Date: 11/28/2022
• Device Model Number: L031-118B5
• Device Catalogue Number: 660261
• Device Lot Number: COV1110226
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 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