BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10451659 · Received August 25, 2020

    Report

    Report Number
    3009976420-2020-00003
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    May 1, 2020
    Report Date
    August 14, 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'S INVESTIGATION OF THE PATIENT RESULTS, RUN RESULTS, AND ADDITIONAL DATA FROM THE CUSTOMER CONCLUDED THAT THE FALSE MS2 AMPLIFICATION IN THE POSITIVE CONTROL WAS DUE TO USER ERROR. SPECIFICALLY, THE USER DID NOT PROPERLY VORTEX AND/OR CENTRIFUGE THE QPCR PLATE ACCORDING TO IFU INSTRUCTIONS AND PROVIDED TRAINING MATERIALS. IN AN ABUNDANCE OF CAUTION, WE ARE REPORTING THIS OCCURRENCE BECAUSE DURING INVESTIGATION WE DETERMINED THAT THE PLATE MIXING ISSUES CAUSED THE CALL IN A SINGLE WELL (1 PATIENT) TO CHANGE FROM TRUE INCONCLUSIVE TO POSITIVE, CONSTITUTING A FALSE POSITIVE. HOWEVER, DUE TO THE PLATE INVALIDATION CAUSED BY THE POSITIVE CONTROL FAILURE, THIS FALSE RESULT WAS INVALIDATED..

    Description of Event or Problem · 1

    CUSTOMER IS OCCASIONALLY SEEING THAT THE POSITIVE CONTROL IS FAILING QC IN THE INTERPRETIVE SOFTWARE V1.2. THERMO FISHER SCIENTIFIC'S TECHNICAL SERVICE DETERMINED THAT MS2 IS CALLING AS POSITIVE, EVEN THOUGH IT WAS NOT ADDED AND APPEARS FLAT IN THE MULTICOMPONENT PLOT. THIS FALSE MS2 AMPLIFICATION INVALIDATED THE PLATE, WHICH PREVENTED ANY FALSE RESULTS FROM BEING REPORTED TO PATIENTS OR THEIR HEALTHCARE PROVIDERS. THERMO FISHER SCIENTIFIC'S INVESTIGATION OF THE PATIENT RESULTS, RUN RESULTS, AND ADDITIONAL DATA FROM THE CUSTOMER CONCLUDED THAT THE FALSE MS2 AMPLIFICATION IN THE POSITIVE CONTROL WAS DUE TO USER ERROR. SPECIFICALLY, THE USER DID NOT PROPERLY VORTEX AND/OR CENTRIFUGE THE QPCR PLATE ACCORDING TO IFU INSTRUCTIONS AND PROVIDED TRAINING MATERIALS. THE CUSTOMER REPORTED NO PATIENT DEATHS OR SERIOUS INJURIES TO THERMO FISHER SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912020 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)

    Patients

    Seq Age Sex Outcome Treatment
    1