BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 11827097 · Received May 14, 2021

    Report

    Report Number
    3009976420-2021-00021
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 14, 2021
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE REVIEW OF THE CUSTOMER SUPPLIED DATA FILES, THERMO FISHER SCIENTIFIC CONFIRMED THREE (3) FALSE POSITIVE RESULTS OUT OF 116 SAMPLES. THE FALSE POSITIVE RESULTS WERE ATTRIBUTED TO AIR BUBBLES IN THE REACTION WELLS THAT POPPED DURING PCR THERMOCYCLING. THIS RESULTED IN NON-SPECIFIC AMPLIFICATION THAT CROSSED THE THRESHOLD AND CAUSED FALSE POSITIVE RESULTS. THE ROOT CAUSE OF THIS ISSUE WAS IDENTIFIED AS THE USER'S IMPROPER CENTRIFUGATION OF THE QPCR PLATE, WHICH PREVENTED THE TRAPPED AIR BUBBLES FROM POPPING PRIOR TO THERMOCYCLING IN PCR. THERMO FISHER SCIENTIFIC INSTRUCTED THE CUSTOMER TO CENTRIFUGE THE QPCR PLATE PROPERLY PER THE INSTRUCTIONS ON PAGE 38 OF THE INSTRUCTIONS FOR USE (MAN0019181, REV. J.0) TO HELP PREVENT RECURRENCE OF THE ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WHILE RUNNING THE TAQPATH" COVID19 COMBO KIT. QUANTSTUDIO 5 PCR INSTRUMENT (96-WELL BLOCK) ON (B)(6) 2021. SUBSEQUENTLY ON THE RE-RUN ON A DIFFERENT PLATFORM, THESE RESULTS WERE NEGATIVE. THERMO FISHER'S INVESTIGATION DETERMINED THAT THE FALSE RESULTS WERE LIKELY CAUSED BY INADEQUATE CENTRIFUGATION OF THE QPCR PLATE. THERMO FISHER WAS ABLE TO CONFIRM THAT THE FALSE POSITIVE RESULTS WERE REPORTED OUT TO THE PHYSICIAN/PATIENT. THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURIES OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724954 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) 2008226

    Patients

    Seq Age Sex Outcome Treatment
    1