BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENABIO COVID-19 RAPID SELF-TEST KIT

    MDR report key: 17975481 · Received October 19, 2023

    Report

    Report Number
    MW5147165
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    October 1, 2023
    Report Date
    October 19, 2023
    Manufacturer
    GENABIO DIAGNOSTICS INC
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED TO REPORT THAT UPON OPENING THEIR COVID-19 RAPID SELF-TEST KIT, IT WAS MISSING THE LIQUID VIAL THAT IS NEEDED FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996125 GENABIO COVID-19 RAPID SELF-TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP GENABIO DIAGNOSTICS INC US220926

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male