BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10457574 · Received August 26, 2020

    Report

    Report Number
    3009976420-2020-00010
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    June 9, 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 · 0

    PREVIOUSLY REPORTED B.6: TWO DATA FILES WERE PROVIDED BY THE CUSTOMER AND REVIEWED BY THERMO FISHER SCIENTIFIC. THE AMPLIFICATION CURVES IN BOTH DATA FILES SHOWED EVIDENCE OF OPTICAL MIXING CAUSED BY INADEQUATE VORTEXING. OF THE 140 CLINICAL SAMPLE WELLS ANALYZED, THERMO FISHER WAS ABLE TO CONFIRM 20 FALSE POSITIVE SAMPLE WELLS. THIS INFORMATION WAS COMMUNICATED TO THE CUSTOMER. CORRECTED B.6 DATA: TWO DATA FILES WERE PROVIDED BY THE CUSTOMER AND REVIEWED BY THERMO FISHER SCIENTIFIC. THE AMPLIFICATION CURVES IN BOTH DATA FILES SHOWED EVIDENCE OF OPTICAL MIXING CAUSED BY INADEQUATE VORTEXING. OF THE 188 CLINICAL SAMPLE WELLS ANALYZED ON THE TWO FILES, THERMO FISHER WAS ABLE TO CONFIRM 21 FALSE POSITIVE SAMPLE WELLS. THIS INFORMATION WAS COMMUNICATED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THERMO FISHER SCIENTIFIC'S REVIEW OF THE PATIENT RESULTS, RUN RESULTS, AND ADDITIONAL DATA FROM THE CUSTOMER, SHOWED THAT THE ROOT CAUSE OF FALSE POSITIVE RESULTS WAS DUE TO USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED "SPORADIC" FALSE POSITIVE RESULTS IN APPROXIMATELY 45 OUT OF 2,500 TESTED PATIENT SAMPLES. BASED ON CUSTOMER FOLLOW-UP, CUSTOMER INDICATED THAT NO FALSE RESULTS WERE REPORTED TO PATIENTS OR THEIR HEALTHCARE PROVIDERS. 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. AFTER TROUBLESHOOTING AND TRAINING, THE CUSTOMER NO LONGER EXPERIENCED THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917546 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) A47814

    Patients

    Seq Age Sex Outcome Treatment
    1