BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID 19 ANTIGEN HOME TEST

    MDR report key: 16067458 · Received December 27, 2022

    Report

    Report Number
    MW5114037
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    December 19, 2022
    Report Date
    December 23, 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

    I TOOK 3 FLOW FLEX COVID ANTIGEN TESTS IN THE WHITE BOX. ALL TESTED FAINTLY POSITIVE. SUBSEQUENTLY I HAD A PCR(POLYMERASE CHAIN REACTION) AND 3 NEGATIVE RAPID TESTS AT A NYC TESTING CENTER. NO SYMPTOMS AND DO NOT HAVE COVID. PLANNED TO VISIT ELDERLY MOTHER SO TESTED AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453167 FLOWFLEX COVID 19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV1120113
    453168 FLOWFLEX COVID 19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV1120113
    453169 FLOWFLEX COVID 19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV1120113

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female LIVALO| VERAPAMIL