MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX OVER-THE-COUNTER COVID TEST; OVER-THE-COUNTER COVID-19 ANTIGEN TEST

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

I am concerned about accuracy of this brand, flowflex.It is the white box, purchased at walgreens.I have on three separate occasions in (b)(6) 2023, (b)(6) 2023, and (b)(6) 2024 taken otc(over-the-counter) flowflex covid test and had faint positives, many times with no symptoms (i am a healthcare worker and test on occasion while asymptomatic).However repeating covid tests with other brands and pcr confirm that i am covid negative.I just want it to be documented in case others have had similar false positives.Reference reports: mw5150706, mw5150707.

• Brand Name: FLOWFLEX OVER-THE-COUNTER COVID TEST
• Type of Device: OVER-THE-COUNTER COVID-19 ANTIGEN TEST
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 18586785
• MDR Text Key: 333957290
• Report Number: MW5150707
• Device Sequence Number: 1
• Product Code: QYT
• 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: 01/23/2024

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White