BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 ANTIGEN TEST

    MDR report key: 16195022 · Received January 17, 2023

    Report

    Report Number
    MW5114350
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    January 15, 2023
    Report Date
    January 16, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED TWO BOXES OF COVID TEST AT HOME KITS. NEITHER BOX HAD SOLUTION. NECESSARY TO PERFORM TEST. WOULD LIKE ANOTHER TWO BOXES THAT HAVE COMPLETE PARTS IN THEM. COVID-19 ANTIGEN SELF TEST DID NOT HAVE DROPPER IN NEITHER OF TWO KITS. EACH KIT CONTAINING 2 TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129460 COVID-19 ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    129461 COVID-19 ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female