BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 12583120 · Received October 5, 2021

    Report

    Report Number
    MW5104393
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 28, 2021
    Report Date
    October 2, 2021
    Manufacturer
    THERMO FISHER SCIENTIFIC, INC. / LIFE TECHNOLOGIES CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FALSE POSITIVE OF PCR COVID TEST ON (B)(6) 2021 FROM (B)(6). TWO TESTS AT DIFFERENT LOCATIONS 2 DAYS LATER ON (B)(6) WERE NEGATIVE - ONE ANTIGEN AND ONE PCR. (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472240 TAQPATH COVID-19 COMBO KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR THERMO FISHER SCIENTIFIC, INC. / LIFE TECHNOLOGIES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR