BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10823887 · Received November 11, 2020

    Report

    Report Number
    3009976420-2020-00031
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 11, 2020
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERMO FISHER SCIENTIFIC'S R&D GROUP ANALYZED THE SEVENTEEN CUSTOMER-SUPPLIED DATA FILES AND CONFIRMED TWENTY (20) FALSE POSITIVE PATIENT SAMPLE RESULTS. THE ROOT CAUSE WAS CONFIRMED TO BE IMPROPER CENTRIFUGATION OF THE QPCR PLATE AND SUSPECTED CONTAMINATION. 8 OF THE FILES HAD TOO MANY N GENE POSITIVES, INDICATING PROBABLE CONTAMINATION OF SOME SORT. THE CUSTOMER ALSO RUNS THE CDC ASSAY; IT'S PROBABLE THAT CONTAMINATION MAY HAVE COME FROM THAT CONTROL. EVEN THOUGH THE CUSTOMER IS RUNNING AN LDT, THE CUSTOMER WAS ADVISED TO FOLLOW INSTRUCTIONS PER THE ASSAY'S INSTRUCTIONS FOR USE CONCERNING PROPER CENTRIFUGATION OF QPCR PLATES.

    Description of Event or Problem · 1

    THE LABORATORY'S MODIFICATION OF THE ASSAY AS AN LDT AND IMPROPER MIXING OF THE PLATE AND PROBABLE CONTAMINATION LED TO THE CUSTOMER REPORTING TO US ON (B)(6) 2020, A HIGH INCIDENCE OF INCONCLUSIVE AND FALSE POSITIVE RESULTS DUE TO N GENE AMPLIFICATION. CUSTOMER IS NOT RUNNING THE THERMO FISHER ASSAY WORKFLOW; THEY ONLY BUY THE ASSAY FROM US AND DO THEIR OWN ANALYSIS WITH THEIR OWN CT CUT-OFF. THE CUSTOMER'S VERSION OF THE TEST HAS NOT BEEN VERIFIED OR VALIDATED BY THERMO FISHER SCIENTIFIC. DURING INVESTIGATION OF THE INITIAL COMPLAINT, CUSTOMER SUPPLIED SEVENTEEN DATA FILES ON 12-OCT-2020. THERMO FISHER SCIENTIFIC'S R&D GROUP ANALYZED THE FILES ON 04-NOV-2020 AND CONFIRMED TWENTY(20) FALSE POSITIVE SAMPLES IN THE DATA FILES PROVIDED. THERMO FISHER SCIENTIFIC WAS UNABLE TO CONFIRM WHETHER THE FALSE POSITIVE RESULTS WERE REPORTED OUT OF THE LAB AND COMMUNICATED TO THE ORDERING PHYSICIAN AND/OR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290467 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) 2005055

    Patients

    Seq Age Sex Outcome Treatment
    1