BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 16387850 · Received February 16, 2023

    Report

    Report Number
    2531491-2023-00525
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    February 8, 2023
    Report Date
    February 16, 2023
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    FALSE POSITIVE RESULT (S). THIS TEST KIT IS USELESS. IT SHOWED COVID 19 FALSE POSITIVE FOR MY WIFE AND NEGATIVE FOR ME. WE TRIED COUPLE OF TIMES MORE BUT MY WIFE RESULT CAME POSITIVE AND MINE NEGATIVE AGAIN. MY WIFE HAD NORMAL ALLERGY SYMPTOMS ITCHY EYES AND SNEEZING. WE WENT FOR A PCR TEST THE SAME DAY AND BOTH OF US RESULTS WERE NEGATIVE. WE WENT FOR PCR TEST AFTER COUPLE OF DAYS AGAIN AND THE RESULTS WERE NEGATIVE. WISH I HAD READ THE REVIEWS BEFORE I BOUGHT THIS TEST KIT. ITS USELESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681148 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP QKP ACON LABORATORIES, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown