BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN RAPID HOME TEST KIT

    MDR report key: 14694870 · Received June 14, 2022

    Report

    Report Number
    MW5110300
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    June 9, 2022
    Report Date
    June 9, 2022
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PERFORMED A FLOWFLEX COVID-19 ANTIGEN RAPID TEST ON MYSELF EARLIER TODAY AND OBSERVED THERE WAS FAINT LINE ON THE NEXT TO THE CONTROL LINE WHICH IMPLIED THAT I HAD TESTED POSITIVE. SINCE THE LINE WAS SO FAINT, I DECIDED TO PERFORM 2 MORE TESTS ON MYSELF AND BOTH WERE NEGATIVE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659028 FLOWFLEX COVID-19 ANTIGEN RAPID HOME TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown