BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOFISHER TAQPATH COMBO KIT TEST

    MDR report key: 12370123 · Received August 25, 2021

    Report

    Report Number
    MW5103495
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    August 16, 2021
    Report Date
    August 23, 2021
    Manufacturer
    THERMO FISHER SCIENTIFIC BALTICS UAB / LIFE TECHNOLOGIES LIMITED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FALSE POSITIVE COVID 19 TEST RESULT WITH THERMOFISHER TAQPATH COMBO KIT TEST. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265634 THERMOFISHER TAQPATH COMBO KIT TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR THERMO FISHER SCIENTIFIC BALTICS UAB / LIFE TECHNOLOGIES LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1