BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 15462212 · Received September 20, 2022

    Report

    Report Number
    MW5112151
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    September 17, 2022
    Report Date
    September 19, 2022
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON SATURDAY ((B)(6) 2022) I RECEIVED TWO (2) FALSE POSITIVE RESULTS USING THE ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST. UPON RECEIVING THE INITIAL POSITIVE RESULTS I SCHEDULE A PCR TEST THE SAME DAY AT MY LOCAL PHARMACY. THE PCR RESULTS CAME BACK ON SUNDAY ((B)(6) 2022) AND THE REPORTED RESULTS WERE NEGATIVE. I PURCHASED A DIFFERENT BRAND OF ANTIGEN HOME TESTS (ABBOTT BINAX) TO ISOLATE THE QUESTIONABLE RESULTS. THE DIFFERENT BRAND TEST RESULTED IN A NEGATIVE RESULT ON SUNDAY (B)(6). OUT OF CURIOSITY I TRIED ANOTHER FLOWFLEX TEST ON MONDAY ((B)(6) 2022) AND RESULTED IN ANOTHER POSITIVE TEST RESULT. ALL THREE POSITIVE RESULTS CAME FROM THE SAME MANUFACTURING LOT NUMBER (COV2020144). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566842 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV2020144
    567807 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV2020144
    567808 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV2020144

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male INSULIN (HUMALOG)