BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 23604268 · Received November 19, 2025

    Report

    Report Number
    MW5179112
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    November 17, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QYT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    COUNTERFEIT COVID TEST. I LOOKED UP THE EXPIRATION DATE OF THE OTC COVID TEST I HAD AT HOME ONLY TO LEARN IT'S COUNTERFEIT. PURCHASED AT A SAFEWAY PHARMACY IN 2024. INSURANCE PAID FOR IT. FRAUD. INS PAID FOR 8 FRAUDULENT TESTS. PT CODE: 4582. DEVICE CODE: 2911. REF REPORTS: MW5179108, MW5179109, MW5179110, MW5179111, MW5179113, MW5179114, MW5179115.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 11/21/2025 FOR REPORT MW5179112 TO UPDATE PROCODE TO QYT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261956 FLOWFLEX COVID-19 ANTIGEN HOME TEST OVER-THE-COUNTER COVID-19 ANTIGEN TEST QYT ACON LABORATORIES, INC. COV3090012/0013

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other