BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-18 ANTIGEN SELF TEST

    MDR report key: 16051201 · Received December 23, 2022

    Report

    Report Number
    MW5114002
    Event Type
    Malfunction
    Date Received
    December 23, 2022
    Date of Event
    December 19, 2022
    Report Date
    December 22, 2022
    Manufacturer
    ABBOTT
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INITIALLY TOOK PILOT COVID TEST THAT CAME BACK POSITIVE USED MULTIPLE OTHER TESTS TO CONFIRM HOWEVER THEY CAME BACK NEGATIVE. WAS ABLE TO CONFIRM POSITIVITY VIA LAB TEST. TOOK MULTIPLE TESTS WHICH CAME BACK NEGATIVE HOWEVER PILOT COVID-19 AT-HOME TEST CAME BACK POSITIVE WHICH WAS CONFIRMED WITH A LAB TEST BINAXNOW - REF: 195-160 EXP: 12/19/2022 LOT: 180075, INBIOS - LOT: BH7160 EXP: 09/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050554 BINAXNOW COVID-18 ANTIGEN SELF TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT 180075
    2050555 INBIOS COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP INBIOS INTERNATIONAL, INC. BH7160

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Other