BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10452164 · Received August 25, 2020

    Report

    Report Number
    3009976420-2020-00011
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    July 6, 2020
    Report Date
    August 14, 2020
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS ADDED TO CAPTURE AN ADDITIONAL 2 DATA FILES THAT WERE PROVIDED BY THE CUSTOMER AND ANALYZED BY THERMO FISHER SCIENTIFIC AFTER THE DATE THAT THE INITIAL MDR WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    THERMO FISHER SCIENTIFIC REVIEWED 4 CUSTOMER DATA FILES WHICH CONTAINED 2 OF THE ALLEGED FALSE POSITIVE RESULTS. DATA FILES FROM ACCESSION # (B)(6) ((B)(6) 2020) WERE NOT PROVIDED. THE ASSAYS WERE RUN ON 96-WELL PLATES ON A 7500 SERIES INSTRUMENT. A REVIEW OF THE CUSTOMER DATA VERIFIED 2 FALSE POSITIVE CALLS DUE TO LATE AMPLIFICATION OF THE VIRAL TARGETS. THREE HUNDRED AND SIXTY EIGHT (368) CLINICAL RESULTS FROM CHEMISYS LABORATORY WERE REVIEWED BY THERMO FISHER SCIENTIFIC. NO OTHER RESULTS EXHIBITED LATE AMPLIFICATIONS OR FALSE CALLS.

    Description of Event or Problem · 1

    (B)(6) CONTACTED THERMO FISHER SCIENTIFIC REGARDING 3 POTENTIAL FALSE POSITIVE RESULTS OBTAINED USING THE TAQPATH COVID-19 COMBO KIT TEST. CUSTOMER CITED A DIP IN FLOURESCENCE IN THE MULTICOMPONENT PLOT. RESULTS WERE PRESUMED TO BE FALSE POSITIVE BECAUSE: ACCESSION # (B)(6) WENT FROM POSITIVE ON (B)(6) 2020 P4 TO INCONCLUSIVE ON (B)(6) 2020 P1. ACCESSION # (B)(6) WENT FROM POSITIVE ON (B)(6) 2020 P6 TO NOT DETECTED (NEGATIVE) ON (B)(6) 2020 P1. ACCESSION # (B)(6) WENT FROM POSITIVE ON (B)(6)2020 P5 TO NOT DETECTED (NEGATIVE) ON (B)(6) 2020 P2. IT IS UNKNOWN IF FALSE RESULTS WERE REPORTED TO HEALTHCARE PROVIDERS OR PATIENTS BECAUSE THE CUSTOMER WAS NOT RESPONSIVE TO 3 FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL DETAILS. THERMO FISHER SCIENTIFIC'S INVESTIGATION OF THE PATIENT RESULTS, RUN RESULTS, AND ADDITIONAL DATA FROM THE CUSTOMER CONCLUDED THAT THE LATE AMPLIFICATION AND FALSE POSITIVE RESULTS WERE DUE TO USER ERROR. SPECIFICALLY, THE USER DID NOT PROPERLY VORTEX AND/OR CENTRIFUGE THE QPCR PLATE ACCORDING TO IFU INSTRUCTIONS AND PROVIDED TRAINING MATERIALS. THE CUSTOMER REPORTED NO PATIENT DEATH OR SERIOUS INJURY TO THERMO FISHER SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912371 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) 2003017

    Patients

    Seq Age Sex Outcome Treatment
    1