BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10880860 · Received November 20, 2020

    Report

    Report Number
    3009976420-2020-00034
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    October 19, 2020
    Report Date
    November 20, 2020
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INVESTIGATION, CUSTOMER SUPPLIED ONE 1 DATA FILE ON 21-OCT-2020. THERMO FISHER SCIENTIFIC'S R&D TEAM ANALYZED THE FILE ON 27-OCT-2020. THE R&D TEAM WAS UNABLE TO CONFIRM THE FALSE POSITIVE RESULTS AS THE CUSTOMER IS USING A NON- VALIDATED WORKFLOW. THE QUANT STUDIO 6 ISN'T VALIDATED AS PART OF OUR COVID-19 EUA WORKFLOW, SO THERE IS NO ESTABLISHED THRESHOLD BY WHICH TO DETERMINE IF THE RESULTS WERE "FALSE" OR NOT. IN THIS SCENARIO, IT'S THE LABORATORY'S RESPONSIBILITY TO PROPERLY SET THE THRESHOLD AND VALIDATE THE WORKFLOW ACCORDINGLY, AS AN LDT.

    Description of Event or Problem · 1

    AN UNVALIDATED INSTRUMENT PLATFORM (QUANT STUDIO 6) WAS USED WITH THE THERMO FISHER EUA TAQPATH COVID-19 ASSAY KIT WHEN FALSE POSITIVE RESULTS WERE ENCOUNTERED BY THE CUSTOMER. THERE ARE NO DATA, CLAIMS OR LABELING TO SUPPORT THE USE OF THE NON-VALIDATED WORKFLOW ON THE UNSUPPORTED INSTRUMENT PLATFORM. THERMO FISHER SCIENTIFIC'S R&D TEAM WAS UNABLE TO ANALYZE THE DATA FILES AS THERE IS NO ESTABLISHED THRESHOLD BY WHICH TO DETERMINE IF THE RESULTS WERE "FALSE" OR NOT. IN THIS SCENARIO, IT'S THE LABORATORY'S RESPONSIBILITY TO PROPERLY SET THE THRESHOLD AND VALIDATE THE WORKFLOW ACCORDINGLY, AS AN LDT. THERMO FISHER REQUESTED CUSTOMER TO USE THERMO FISHER SCIENTIFIC'S VALIDATED EUA WORKFLOW ON A SUPPORTED INSTRUMENT PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345370 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)

    Patients

    Seq Age Sex Outcome Treatment
    1