BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10881780 · Received November 22, 2020

    Report

    Report Number
    3009976420-2020-00036
    Event Type
    Malfunction
    Date Received
    November 22, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 22, 2020
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT PROVIDED DATA FILES TO FACILITATE COMPLAINT INVESTIGATION DESPITE MULTIPLE ATTEMPTS BY THERMO FISHER SCIENTIFIC TO OBTAIN THIS INFORMATION. COMPLAINT COULD NOT BE CONFIRMED NOR CAUSE ESTABLISHED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2020 CUSTOMER REPORTED SIX (6) FALSE POSITIVE PATIENT RESULTS. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED DUE TO THE CUSTOMER NOT PROVIDING SOFTWARE DATA FILES FOR THE SUSPECTED PCR RUN(S). THERMO FISHER SCIENTIFIC FIELD/TECHNICAL APPLICATION SPECIALISTS CONTACTED THE CUSTOMER MULTIPLE TIMES IN AN ATTEMPT TO RETRIEVE DATA FILES. THERMO FISHER CONFIRMED PATIENT RESULTS WERE REPORTED OUT OF THE LAB TO THE ORDERING PHYSICIAN AND/OR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346678 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