BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10457527 · Received August 26, 2020

    Report

    Report Number
    3009976420-2020-00012
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    July 1, 2020
    Report Date
    August 26, 2020
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERMO FISHER SCIENTIFIC REVIEWED PATIENT RESULTS, RUN RESULTS, AND ADDITIONAL DATA FROM THE CUSTOMER. ROOT CAUSE WAS DETERMINED TO BE: USER DID NOT PROPERLY VORTEX AND/OR CENTRIFUGE THE QPCR PLATE ACCORDING TO IFU INSTRUCTIONS.

    Description of Event or Problem · 1

    CUSTOMER IS NOT FOLLOWING APPROVED EUA WORKFLOW AND IFU. A CUSTOMER REPORTED FALSE POSITIVE RESULTS WHEN USING THE TAQPATH COVID-19 COMBO KIT FOR AN OFF-LABEL USE. THE CUSTOMER REPORTED NO PATIENT DEATH OR SERIOUS INJURY TO THERMO FISHER SCIENTIFIC. THERMO FISHER SCIENTIFIC'S REVIEW OF THE PATIENT RESULTS, RUN RESULTS, AND ADDITIONAL DATA FROM THE CUSTOMER, SHOWED THAT THE FALSE POSITIVE RESULTS WERE DUE TO USER ERROR. SPECIFICALLY, THE USER DID NOT PROPERLY VORTEX AND/OR CENTRIFUGE THE QPCR PLATE ACCORDING TO IFU INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917340 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)

    Patients

    Seq Age Sex Outcome Treatment
    1