BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH¿ RT-PCR COVID-19, FLUA, FLUB KIT

    MDR report key: 15677030 · Received October 26, 2022

    Report

    Report Number
    3009976420-2022-00006
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    September 22, 2022
    Report Date
    November 22, 2022
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME THE ROOT CAUSE IS UNKNOWN. THERMO FISHER SCIENTIFIC TESTED RETAIN MATERIAL FROM THE IMPACTED LOT AND CONFIRMED THAT THE ASSAY COMPONENTS ARE PERFORMING AS EXPECTED. BASED ON THE PRELIMINARY INVESTIGATION, THE ISSUE MAY BE RELATED TO THE SPECIFIC INSTRUMENT OR POSSIBLE VARIATIONS IN WORKFLOW BEING USED BY THE CUSTOMER. THIS INVESTIGATION IS ONGOING, AND A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE A ROOT CAUSE IS DETERMINED. ADDITIONAL INFORMATION 22NOV2022: THERMO FISHER SCIENTIFIC WAS UNABLE TO REPRODUCE THE ISSUE THE CUSTOMER WAS EXPERIENCING USING LOT RETAIN MATERIAL; HOWEVER, FURTHER DISCUSSION WITH THE CUSTOMER INDICATED THAT THE CUSTOMER MAY HAVE USED THE WRONG ASSAY MIX WITH THE TEST. THE CUSTOMER ALIQUOTS ASSAY MIX IN ADVANCE AND STORES IT IN THE FREEZER. OUR R&D TEAM WAS ABLE TO CONFIRM THAT USING THE WRONG ASSAY MIX (TAQPATH COVID-19 COMBO KIT REAGENTS INSTEAD OF TAQPATH¿ RT-PCR COVID-19, FLUA, FLUB KIT REAGENTS) COULD GIVE RESULTS WITH THE SAME PHENOTYPE THAT THE CUSTOMER REPORTED. AN APPLICATIONS SCIENTIST WAS SENT TO THE CUSTOMER'S SITE TO REVIEW THE WORKFLOW WITH THE CUSTOMER, AND THEY HAVE NOT EXPERIENCED SIMILAR ISSUES SINCE.

    Additional Manufacturer Narrative · 0

    AT THIS TIME THE ROOT CAUSE IS UNKNOWN. THERMO FISHER SCIENTIFIC TESTED RETAIN MATERIAL FROM THE IMPACTED LOT AND CONFIRMED THAT THE ASSAY COMPONENTS ARE PERFORMING AS EXPECTED. BASED ON THE PRELIMINARY INVESTIGATION, THE ISSUE MAY BE RELATED TO THE SPECIFIC INSTRUMENT OR POSSIBLE VARIATIONS IN WORKFLOW BEING USED BY THE CUSTOMER. THIS INVESTIGATION IS ONGOING, AND A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE A ROOT CAUSE IS DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED AN INCREASE IN DUAL POSITIVE SAMPLES FOR COVID-19 AND FLU A WHILE USING THERMO FISHER SCIENTIFIC'S TAQPATH¿ RT-PCR COVID-19, FLUA, FLUB KIT ON THEIR 7500 FASTDX PCR INSTRUMENT, BETWEEN (B)(6) 2022 AND (B)(6) 2022. AFTER REVIEW OF THE DATA PROVIDED BY THE CUSTOMER, THERMO FISHER SCIENTIFIC WAS ABLE TO CONFIRM THAT TEN (10) OF THE SUSPECTED DUAL POSITIVE CALLS WERE FALSE POSITIVE FOR FLU A WHILE GIVING TRUE POSITIVE RESULTS FOR COVID-19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2761718 TAQPATH¿ RT-PCR COVID-19, FLUA, FLUB KIT TAQPATH¿ RT-PCR COVID-19, FLUA, FLUB KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown