BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10687633 · Received October 15, 2020

    Report

    Report Number
    3009976420-2020-00027
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 10, 2020
    Report Date
    October 15, 2020
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERMO FISHER SCIENTIFIC'S R&D GROUP ANALYZED THE 1 CUSTOMER SUPPLIED DATA FILE ON 24-SEP-2020: COVID (B)(6) 2020. THEY CONFIRMED A FALSE POSITIVE RESULT DUE TO A BUBBLE IN ONE OF THE REACTION WELLS. THE ROOT CAUSE WAS DETERMINED TO BE IMPROPER CENTRIFUGATION TO RELEASE TRAPPED AIR BUBBLES. CUSTOMER WAS INSTRUCTED BY THERI THERMO FISHER FIELD APPLICATIONS SCIENTIST TO FOLLOW THE ASSAY'S INSTRUCTIONS FOR USE REGARDING PROPER CENTRIFUGATION.

    Description of Event or Problem · 1

    LABORATORY'S IMPROPER CENTRIFUGATION OF THE QPCR PLATE LED TO ONE FALSE POSITIVE PATIENT SAMPLE CALL. ON (B)(6) 2020 THE CUSTOMER REPORTED A SAMPLE GAVE A POSITIVE CALL AND THERE WAS A SLIGHT INCREASE IN THE SIGNAL DUE TO A BUBBLE. THE CUSTOMER PROVIDED 1 SOFTWARE DATA LOG FOR REVIEW. THERMO FISHER SCIENTIFIC'S TECHNICAL AND FIELD APPLICATION SCIENTISTS' TEAMS REVEALED ISSUES WITH POOR CENTRIFUGATION DUE TO USER ERROR. DURING REVIEW OF THE DATA FILE, THERMO FISHER SCIENTIFIC WAS ABLE TO CONFIRM 1 FALSE POSITIVE SAMPLE. THE CUSTOMER DID NOT REPORT ANY DEATHS OR SERIOUS INJURIES. THERMO FISHER SCIENTIFIC WAS NOT ABLE TO CONFIRM WHETHER OR NOT THE FALSE POSITIVE RESULT WAS REPORTED OUT OF THE LAB AND COMMUNICATED TO THE ORDERING PHYSICIAN AND/OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147149 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT, QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)

    Patients

    Seq Age Sex Outcome Treatment
    1