BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX

    MDR report key: 14336822 · Received May 6, 2022

    Report

    Report Number
    MW5109583
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 27, 2022
    Report Date
    May 4, 2022
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    UNABLE TO USE ANTIGEN HOME / TEST; I CAUGHT COVID (B)(6) 2022. SICK WITH "4 DEGREE" TEMP ON (B)(6) 2022. BY (B)(6) 2022 WENT TO (B)(6) TO GET ACON FLOWFLEX COVID ANTIGEN HOME TEST. WENT HOME. TRIED TO USE TEST. STEP 8 NOT POSSIBLE, "DROPPER CAP" TOO BIG TO FIT IN VIAL. MAJOR MANUFACTURING FLAW. NO TEST DONE. CALLED THE HELP LINE TO REPORT IT. THEY DID NOT BELIEVE ME. THIS PRODUCT SHOULD BE RECALLED. LOT: COV1120165 ASAP. PLEASE CONFIRM AND LET ME KNOW. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379837 FLOWFLEX CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV1120165

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other