BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWFLEX COVID ANTIGEN HOME TEST

    MDR report key: 15066842 · Received July 19, 2022

    Report

    Report Number
    MW5110961
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    July 17, 2022
    Report Date
    July 17, 2022
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS USING AT HOME TEST AND GETTING NEGATIVE RESULTS AFTER EXPOSURE. ENDED UP WITH 103.2 FEVER AND WENT TO ER. TESTED POSITIVE AT ER, CAME HOME SAME DAY, USED AT HOME TEST AGAIN JUST TO SEE ACCURACY, STILL GETTING NEGATIVE RESULT. GETTING THIS SICK COULD HAVE BEEN PREVENTED WITH ACCURATE TEST AT HOME. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252314 FLOWFLEX COVID ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC.
    252315 FLOWFLEX COVID ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other| S| R