BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 13261754 · Received January 14, 2022

    Report

    Report Number
    3009976420-2022-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    November 11, 2021
    Report Date
    January 14, 2022
    Manufacturer
    )
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING REVIEW OF THE FOUR (4) CUSTOMER SUPPLIED DATA FILES, THERMO FISHER SCIENTIFIC R&D IDENTIFIED FLUCTUATING BASELINES IN THE AMPLIFICATION CURVES, WHICH RESULTED IN FIVE (5) FALSE POSITIVE CALLS; HOWEVER, NO PROBLEM WAS DETECTED WITH THE ASSAY IN THE TAQPATH¿ COVID-19 COMBO KIT. THE SOURCE OF THE FLUCTUATING BASELINES IS LIKELY INSTRUMENT OR ENVIRONMENT RELATED, BUT THE ROOT CAUSE IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DURING REVIEW OF THE FOUR (4) CUSTOMER SUPPLIED DATA FILES, THERMO FISHER SCIENTIFIC R&D IDENTIFIED FLUCTUATING BASELINES IN THE AMPLIFICATION CURVES, WHICH RESULTED IN FIVE (5) FALSE POSITIVE CALLS; HOWEVER, NO PROBLEM WAS DETECTED WITH THE ASSAY IN THE TAQPATH¿ COVID-19 COMBO KIT. THE SOURCE OF THE FLUCTUATING BASELINES IS LIKELY INSTRUMENT OR ENVIRONMENT RELATED, BUT THE ROOT CAUSE IS STILL UNDER INVESTIGATION. UPDATE 11-FEB-2022: THERMO FISHER SCIENTIFIC REVIEWED THE SERVICE HISTORY FOR THE QUANTSTUDIO 5 PCR INSTRUMENT (SN# (B)(6) ) AT SUTTER HEALTH AND VERIFIED THAT THE INSTRUMENT WAS INSTALLED ON 01-SEP-2020. SERVICE CALLS WERE OPENED FOR PREVENTATIVE MAINTENANCE AND REQUALIFICATION AND THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE INSTRUMENT PASSED ALL FUNCTIONAL TESTING DURING THE SCHEDULED VISITS. THE FSE PROVIDED NEW INFORMATION FROM A SITE VISIT ON 03-FEB-2022 CONFIRMING THAT THE INSTRUMENT DATA FILES DID NOT INDICATE ANY ADDITIONAL OCCURRENCES OF FLUCTUATING BASELINES OR FALSE RESULTS DURING CONTINUED USE OF THE INSTRUMENT. THERMO FISHER SCIENTIFIC R&D DETERMINED THE PROBABLE SOURCE OF THE FLUCTUATING BASELINES IS LIKELY INSTRUMENT OR ENVIRONMENT RELATED; HOWEVER, THE EXACT ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INCREASE IN FALSE POSITIVE AND INCONCLUSIVE SAMPLES THAT THEY BELIEVED WAS CORRELATED WITH TAQPATH COMBO KIT ASSAY LOT# 2109366. THEY ELECTED TO RETEST SOME SAMPLES WITHOUT RE-EXTRACTING AND IN THE REPEAT RUNS, SEVERAL POSITIVE RESULTS REPEATED AS NEGATIVE OR INCONCLUSIVE. THE CUSTOMER WAS USING A QUANTSTUDIO 5 PCR INSTRUMENT (96 WELL BLOCK) AND THE RUNS IN QUESTION WERE PERFORMED ON (B)(6) 2021. THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURIES OR DEATH. THERMO FISHER SCIENTIFIC WAS ABLE TO CONFIRM THAT THE FALSE POSITIVE RESULTS WERE REPORTED OUT TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754948 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR ) 2109366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown