BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 TEST KIT

    MDR report key: 16910574 · Received May 10, 2023

    Report

    Report Number
    MW5117446
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    May 10, 2023
    Report Date
    May 10, 2023
    Manufacturer
    MAXIM BIOMEDICAL, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A REPORTER CALLED TO REPORT THAT SHE RECEIVED 9 COVID-19 TEST KITS. SHE SAID HER SON AND HER USED 4 OUT OF 9 KITS AND NONE OF THEM WORK. REPORTER SAID THE ORIGINAL EXPIRATION DATE WAS NOVEMBER 18, 2022 BUT IT WAS EXTENDED TO MAY 18, 2023. REF REPORTS: MW5117444, MW5117445, MW5117447.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164984 COVID-19 TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. MB26MAY2201

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female