BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWFLEX

    MDR report key: 20532649 · Received October 24, 2024

    Report

    Report Number
    MW5161553
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    October 19, 2024
    Report Date
    October 19, 2024
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT THE TEST WHICH PROVIDED A FALSE NEGATIVE. MY SYMPTOMS HAVE GOTTEN WORSE AND MY CHILDREN WERE TESTED AT THE HOSPITAL WHICH CONFIRMED THEY DO HAVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972517 FLOWFLEX CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV3100001

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Disability