BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 16376535 · Received February 14, 2023

    Report

    Report Number
    2531491-2023-00238
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    February 7, 2023
    Report Date
    February 14, 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). I BOUGHT 3 FOR MY KIDS AND I. WE ALL TESTED COVID POSITIVE AND A DAY AND HALF LATER, WE TESTED NEGATIVE AT DOCTOR'S OFFICE. WASTE OF MONEY AND INACCURATE. RUINED OUR NYE PLANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944336 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