BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10557260 · Received September 18, 2020

    Report

    Report Number
    3009976420-2020-00021
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 18, 2020
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERMO FISHER SCIENTIFIC REVIEWED AND ANALYZED 4 SOFTWARE DATA LOG FILES PROVIDED BY THE CUSTOMER, AND IDENTIFIED 7 FALSE POSITIVE CALLS AMONGST THE 376 PATIENT SAMPLES. ON (B)(6) 2020, YELLOW3. EDS TWO (2) SAMPLES FALSELY CALLED POSITIVE: SAMPLES (B)(6). ON (B)(6) 2020, BLUE2. EDS: TWO (2) SAMPLES FALSELY CALLED POSITIVE: SAMPLES (B)(6). ON (B)(6) 2020, RED3. EDS: TWO (2) SAMPLES FALSELY CALLED POSITIVE: SAMPLES (B)(6). ON (B)(6) 2020, ORANGE1.EDS: ONE (1) SAMPLE FALSELY CALLED POSITIVE: SAMPLE (B)(6). THE ROOT CAUSE WAS DETERMINED TO BE INSUFFICIENT CENTRIFUGATION OF THE QPCR PLATE, RESULTING IN BUBBLES INSIDE THE REACTION WELLS. THE CUSTOMER WAS INSTRUCTED ON PROPER CENTRIFUGATION PROTOCOL PER OUR INSTRUCTIONS FOR USE TO PREVENT BUBBLE EVENTS AND HAS NOT REPORTED ADDITIONAL ISSUES TO THERMO FISHER SCIENTIFIC SINCE.

    Description of Event or Problem · 1

    THE CUSTOMER HAD COVID RESULTS SHOWING AS POSITIVE BY OUR INTERPRETIVE SOFTWARE. AFTER SEEING THE FDA SAFETY NOTIFICATION, CUSTOMER BECAME CONCERNED, AND CONTACTED THEIR THERMO FISHER SCIENTIFIC FIELD APPLICATIONS SCIENTIST (FAS) TO HELP DETERMINE THIS PROBLEM. UPON REVIEW OF THE AMPLIFICATION CURVES, THE FAS IDENTIFIED 1 PATIENT SAMPLE ((B)(6)) THAT APPEARED TO BE A FALSE POSITIVE RESULT. THE FAS COLLECTED 4 SOFTWARE DATA LOG FILES FROM THE CUSTOMER'S INSTRUMENT AND SENT THEM INTO THERMO FISHER SCIENTIFIC FOR ANALYSIS. QPCR INSTRUMENT: QUANTSTUDIO 5. LDT OR EUA: EUA. INTERPRETIVE SOFTWARE VERSION: (B)(4). 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 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. THERMO FISHER WAS NOT ABLE TO CONFIRM WHETHER OR NOT ANY FALSE RESULTS WERE REPORTED TO PHYSICIANS/PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017306 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) 2005132

    Patients

    Seq Age Sex Outcome Treatment
    1