BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTIGEN TESTS FOR RAPID DETECTION OF SARS-COV-2

    MDR report key: 10958313 · Received December 4, 2020

    Report

    Report Number
    MW5098217
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 23, 2020
    Report Date
    December 2, 2020
    Manufacturer
    UNK
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WE TOOK OUR SON TO (B)(6) PEDIATRICS IN (B)(6) ON (B)(6) 2020 FOR A SUSPECTED EAR INFECTION. WHILE THERE, THE NURSE PERFORMED AN ANTIGEN TESTS FOR SARS-COV-2. THE TEST CAME BACK POSITIVE. THE NEXT DAY, WE HAD OUR SON SWABBED FOR A MOLECULAR TEST THAT CAME BACK NEGATIVE. WE FOLLOWED UP 6 DAYS LATER WITH ANOTHER MOLECULAR TEST THAT WAS NEGATIVE. EVERYONE IN OUR IMMEDIATE FAMILY ALSO TESTED NEGATIVE. I'M UNSURE OF WHICH RAPID TEST THEY DOCTORS OFFICE USES, BUT I BELIEVE THAT IT IS UNRELIABLE. HERE IS THE INFO FROM THE TEST: LOT # M121551, TEST ID: (B)(4), INSTRUMENT SERIAL # (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415189 ANTIGEN TESTS FOR RAPID DETECTION OF SARS-COV-2 CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP UNK M121551

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Other