BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 11128397 · Received January 6, 2021

    Report

    Report Number
    3009976420-2020-00041
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 5, 2020
    Report Date
    January 6, 2021
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INVESTIGATION, THE CUSTOMER SUPPLIED 2 DATA FILES ON 07-DEC-2020, WHICH WERE ANALYZED BY THERMO FISHER SCIENTIFIC'S R&D TEAM ON 09-DEC-2020. THE R&D TEAM WAS UNABLE TO CONFIRM THE FALSE POSITIVE RESULTS AS THE CUSTOMER IS USING A NON- VALIDATED WORKFLOW. HOWEVER, R&D WAS ABLE TO CONFIRM ISSUES WITH SAMPLE HANDLING AND NOTED THAT RECALIBRATION OF THE INSTRUMENT MAY BE NECESSARY. IN ADDITION, SOME OF THE AMPLIFICATION CURVES WERE INDICATIVE OF IMPROPER CENTRIFUGATION AND MIXING OF QPCR PLATES. THIS INFORMATION WAS COMMUNICATED BACK TO THE CUSTOMER. FINALLY, THE CUSTOMER IS USING AUTO THRESHOLDING TO MAKE CYCLE THRESHOLD CALLS BASED ON THE INDIVIDUAL RUN'S DATA. THEREFORE, THE CUSTOMER'S CLAIMS OF THE FALSE CALLS COULD NOT BE VERIFIED DUE TO LACK OF A VALIDATED THRESHOLD FOR MAKING CLINICAL CALLS. AS A LABORATORY DEVELOPED TEST, IT'S THE LABORATORY'S RESPONSIBILITY TO SET AN APPROPRIATE THRESHOLD AND TO VALIDATE THEIR WORKFLOW ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    DURING INVESTIGATION, THE CUSTOMER SUPPLIED TWO (2) DATA FILES ON 07-DEC-2020, WHICH WERE ANALYZED BY THERMO FISHER SCIENTIFIC'S R&D TEAM ON 09-DEC-2020. THE R&D TEAM WAS UNABLE TO CONFIRM THE FALSE POSITIVE RESULTS AS THE CUSTOMER IS USING A NON- VALIDATED WORKFLOW. HOWEVER, R&D WAS ABLE TO CONFIRM ISSUES WITH SAMPLE HANDLING AND NOTED THAT RECALIBRATION OF THE INSTRUMENT MAY BE NECESSARY. IN ADDITION, SOME OF THE AMPLIFICATION CURVES WERE INDICATIVE OF IMPROPER CENTRIFUGATION AND MIXING OF QPCR PLATES. THIS INFORMATION WAS COMMUNICATED BACK TO THE CUSTOMER. FINALLY, THE CUSTOMER IS USING AUTO THRESHOLDING TO MAKE CYCLE THRESHOLD CALLS BASED ON THE INDIVIDUAL RUN'S DATA. THEREFORE, THE CUSTOMER'S CLAIMS OF THE FALSE CALLS COULD NOT BE VERIFIED DUE TO LACK OF A VALIDATED THRESHOLD FOR MAKING CLINICAL CALLS. AS A LABORATORY DEVELOPED TEST, IT'S THE LABORATORY'S RESPONSIBILITY TO SET AN APPROPRIATE THRESHOLD AND TO VALIDATE THEIR WORKFLOW ACCORDINGLY. CORRECTION 25-MAY-2021: THE "DATE OF THIS REPORT" IN THIS INITIAL MDR WAS MISTAKENLY ENTERED AS "06-JAN-2020" AND IS BEING CORRECTED TO "06-JAN-2021" IN THIS FOLLOW-UP. ALSO, THE MFR REPORT # WAS ENTERED AS 3009976420-2020-00041, BUT SHOULD HAVE BEEN 3009976420-2021-00001, SINCE IT WAS SUBMITTED AFTER THE FIRST OF THE YEAR, 2021. HOWEVER, SINCE 3009976420-2021-00001 WAS USED FOR THE NEXT MDR THAT WE SUBMITTED, THIS MDR WILL REMAIN -00041. ALL OTHER INFORMATION REMAINS UNCHANGED.

    Description of Event or Problem · 1

    AN UNVALIDATED INSTRUMENT PLATFORM (QUANTSTUDIO 12K) WAS USED WITH THE THERMO FISHER SCIENTIFIC EUA TAQPATH COVID-19 ASSAY KIT WHEN FALSE POSITIVE RESULTS WERE ENCOUNTERED BY THE CUSTOMER. THERMO FISHER SCIENTIFIC HAS NO DATA, CLAIMS OR LABELING TO SUPPORT THE USE OF THE NON-VALIDATED WORKFLOW ON THE UNSUPPORTED INSTRUMENT PLATFORM. THE LABORATORY STATED THAT 9 POTENTIAL FALSE POSITIVE RESULTS WERE REPORTED OUT OF THE LAB AND COMMUNICATED TO THE ORDERING PHYSICIANS AND/OR PATIENTS. THERMO FISHER'S R&D TEAM ANALYZED THE CUSTOMER-SUPPLIED SOFTWARE DATA FILES, BUT WAS NOT ABLE TO DETERMINE IF THE SAMPLE CALLS WERE FALSE OR NOT, AS THERE IS NO ESTABLISHED THRESHOLD BY WHICH TO MAKE THIS DETERMINATION. AS A LABORATORY DEVELOPED TEST, IT IS THE LABORATORY'S RESPONSIBILITY TO SET AN APPROPRIATE THRESHOLD AND TO VALIDATE THEIR WORKFLOW. THERMO FISHER REQUESTED THAT THE CUSTOMER FOLLOWS THERMO FISHER'S VALIDATED EUA COVID-19 WORKFLOW ON A SUPPORTED INSTRUMENT PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20658 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) 2005141

    Patients

    Seq Age Sex Outcome Treatment
    1