BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10880874 · Received November 21, 2020

    Report

    Report Number
    3009976420-2020-00035
    Event Type
    Malfunction
    Date Received
    November 21, 2020
    Date of Event
    October 21, 2020
    Report Date
    November 20, 2020
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020, CUSTOMER REPORTED ONE (1) FALSE POSITIVE PATIENT RESULT WITH USE OF TAQPATH COVID-19 ASSAY KIT. DURING INVESTIGATION, THE CUSTOMER SUPPLIED TWO (2) SOFTWARE DATA LOG FILES ON (B)(6) 2020, WHICH WERE ANALYZED BY THERMO FISHER SCIENTIFIC'S R&D TEAM ON 02-NOV-2020: (B)(4). ONE (1) FALSE POSITIVE PATIENT RESULT WAS CONFIRMED. THE ROOT CAUSE WAS CONFIRMED TO BE IMPROPER VORTEXING OF THE QPCR PLATE. CUSTOMER WAS ADVISED TO FOLLOW INSTRUCTIONS PER THE ASSAY'S INSTRUCTIONS FOR USE CONCERNING PROPER VORTEXING OF QPCR PLATE.

    Description of Event or Problem · 1

    CUSTOMER'S INSUFFICIENT VORTEXING CAUSED A FALSE POSITIVE PATIENT RESULT. THE FALSE POSITIVE RESULT WAS REPORTED TO THERMO FISHER SCIENTIFIC ON (B)(6) 2020. THE CUSTOMER WAS ADVISED TO FOLLOW INSTRUCTIONS FOR PROPER VORTEXING. THERE ARE NO REPORTS OF SERIOUS INJURY, OR DEATH. THERMO FISHER SCIENTIFIC WAS UNABLE TO CONFIRM IF 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
    1346159 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) 2006148

    Patients

    Seq Age Sex Outcome Treatment
    1