BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10497202 · Received September 4, 2020

    Report

    Report Number
    3009976420-2020-00017
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 7, 2020
    Report Date
    September 4, 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 AND ANALYZED 1 SOFTWARE DATA LOG FILE PROVIDED BY THE CUSTOMER AND IDENTIFIED 3 FALSE POSITIVE CALLS AMONGST THE 81 PATIENT SAMPLES. THE ROOT CAUSE WAS DETERMINED TO BE INSUFFICIENT MIXING AND VORTEXING OF THE QPCR PLATE. THE FOLLOWING DATA FILES CONTAINED FALSE POSITIVE RESULTS: FILE "COVID003.EDS" HAD 3 FALSE POSITIVE CALLS, 47 INCONCLUSIVE CALLS. THE POSITIVE AND NEGATIVE CONTROL PASSED. THE THERMO FISHER FIELD APPLICATION SCIENTIST ASSIGNED TO THIS ACCOUNT RE-TRAINED THE CUSTOMER TO VORTEX THE PLATES ACCORDING TO THE INSTRUCTIONS IN THE IFU, SPECIFICALLY MIXING PROTOCOL AND VORTEXING INSTRUCTIONS. THE CUSTOMER REPEATED THE RUN, SINCE THEN THE CUSTOMER HAS NOT REPORTED ADDITIONAL PROBLEMS.

    Description of Event or Problem · 1

    CUSTOMER SUBMITTED A COMPLAINT ON 08/07/2020 STATING THAT THE RESULTS FROM INTERPRETATIVE SOFTWARE DID NOT MATCH AMPLIFICATION PLOTS IN QUANTSTUDIO 3/5 SOFTWARE INDICATING POTENTIAL FALSE POSITIVE RESULTS. ANALYSIS OF THE CUSTOMER'S DATA BY THERMO FISHER SCIENTIFIC'S TECHNICAL AND FIELD APPLICATIONS SCIENTIST TEAMS REVEALED SYSTEMATIC ISSUES WITH OPTICAL MIXING, DUE TO INSUFFICIENT VORTEXING OF THE QPCR PLATES. TECHNICAL AND FIELD APPLICATIONS SCIENTIST TEAM REQUESTED FOR CUSTOMER TO REPEAT THE RUN AND WAS INSTRUCTED TO FOLLOW THE INSTRUCTIONS FOR USE. THE CUSTOMER DID NOT REPORT ANY DEATHS OR SERIOUS INJURIES TO THERMO FISHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957081 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) 2005120

    Patients

    Seq Age Sex Outcome Treatment
    1