BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 14976356 · Received July 8, 2022

    Report

    Report Number
    MW5110768
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    July 6, 2022
    Report Date
    July 6, 2022
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FLOFLEX COVID-19 ANTIGEN HOME TEST (WHITE BOX) PROVIDED PROBABLE FALSE POSITIVE (NEGATIVE RESULTS USING DIFFERENT LOT OF SAME TEST, AND ALSO NEGATIVE USING IHEALTH TEST). PATIENT CURRENTLY SHOWING NO SYMPTOMS. NUMBERS FROM LABEL ON BOX OF DEFECTIVE TEST: LOT COV2020169 2023-02-23 (O1)00682607660261 (17)230223 (10)COV2020169 MADE IN CHINA L031319-01. THIS WAS A WHITE BOX, NOT THE DARK BLUE BOX SHOWN IN HTTPS://WWW.FDA.GOV/MEDICAL-DEVICES/SAFETY-COMMUNICATIONS/DO-NOT-USE-CERTAIN-ACON-FLOWFLEX-COVID-19-TESTS-FDA-SAFETY-COMMUNICATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396144 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. UPC 6 82607 66026 1 COVID2020169

    Patients

    Seq Age Sex Outcome Treatment
    1 Female 81MG ASPRIN| B-100 SUPPLEMENT| LOSARTAN | MULTIVITAMIN| POTASSIUM 50 MG| SYNTHROID 150 MCG