BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10457409 · Received August 26, 2020

    Report

    Report Number
    3009976420-2020-00014
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    June 25, 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 2 CUSTOMER FILES WHICH CONTAINED THE 3 ALLEGED FALSE POSITIVE RESULTS. A REVIEW OF THE CUSTOMER DATA SHOWED THAT 2 OF THE 3 RESULTS WERE LIKELY NEAR LOD AND CORRECTLY CALLED POSITIVE. ONE (1) SAMPLE WAS DETERMINED TO BE A FALSE POSITIVE DUE TO BASELINE NOISE THAT SHOWED THREE CYCLES OF GROWTH AND WAS PICKED UP BY THE SOFTWARE AS TRUE AMPLIFICATION.

    Description of Event or Problem · 1

    (B)(6) CONTACTED THERMO FISHER SCIENTIFIC REGARDING 3 POTENTIAL FALSE POSITIVE RESULTS OBTAINED USING THE TAQPATH COVID-19 COMBO KIT TEST. RESULTS WERE PRESUMED TO BE FALSE POSITIVE AFTER THE SAME SAMPLES WERE TESTED WITH A HOLOGIC COVID-19 TEST AND RESULTS CAME BACK NEGATIVE. THE CUSTOMER REPORTED NO PATIENT DEATH OR SERIOUS INJURY TO THERMO FISHER SCIENTIFIC. A REVIEW OF THE CUSTOMER DATA SHOWED THAT 2 OF THE 3 RESULTS WERE LIKELY NEAR LOD AND CORRECTLY CALLED POSITIVE. FOLLOW-UP COMMUNICATION WITH THE CUSTOMER CONFIRMED THAT ALLEGED FALSE RESULTS WERE NOT REPORTED TO HEALTHCARE PROVIDERS OR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917191 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)

    Patients

    Seq Age Sex Outcome Treatment
    1