BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10451891 · Received August 25, 2020

    Report

    Report Number
    3009976420-2020-00005
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    May 6, 2020
    Report Date
    August 10, 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

    INSTRUMENT DATA LOG FILES WERE REVIEWED BY THERMO FISHER SCIENTIFIC. 7500-SERIES INSTRUMENT: PATIENT WELL GIVES A FALSE POSITIVE CALL (1) DUE TO INADEQUATE CENTRIFUGATION (TRAPPED AIR BUBBLE). QUANT STUDIO 12K INSTRUMENT (OFF-LABEL): FILES SHOW LATE MS2 AMPLIFICATION, LIKELY DUE TO MS2 REAGENT HANDLING AND BUBBLES DUE TO INADEQUATE CENTRIGURATION. THERMO FISHER SCIENTIFIC'S INVESTIGATION OF THE PATIENT RESULTS, RUN RESULTS, AND ADDITIONAL DATA FROM THE CUSTOMER, CONCLUDED 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 AND PROVIDED TRAINING MATERIALS.

    Description of Event or Problem · 1

    CUSTOMER SUBMITTED 4 DATA FILES WITH SEVERAL SAMPLES THAT DID NOT APPEAR TO AMPLIFY (VIRAL TARGETS OR MS2 CONTROL). MOST WERE CALLED AS NA BY THE INTERPRETIVE SOFTWARE V1.2. HOWEVER, THERE WERE A FEW SAMPLES THAT REPORTED POTENTIALLY FALSE CALLS. THERMO FISHER SCIENTIFIC'S INVESTIGATION OF THE PATIENT RESULTS, RUN RESULTS, AND ADDITIONAL DATA FROM THE CUSTOMER, CONCLUDED 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 AND PROVIDED TRAINING MATERIALS. AFTER TROUBLESHOOTING, THE CUSTOMER AGREED TO RE-RUN THE IMPACTED ASSAY PLATES; NO POTENTIALLY FALSE RESULTS WERE REPORTED TO PATIENTS OR THEIR HEALTHCARE PROVIDERS. THE CUSTOMER REPORTED NO PATIENT DEATHS OR SERIOUS INJURIES TO THERMO FISHER SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912032 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)

    Patients

    Seq Age Sex Outcome Treatment
    1