BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10570715 · Received September 22, 2020

    Report

    Report Number
    3009976420-2020-00023
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    July 27, 2020
    Report Date
    September 22, 2020
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING REVIEW OF THE CUSTOMER-SUPPLIED SOFTWARE DATA FILES, THERMO FISHER SCIENTIFIC IDENTIFIED FIVE (5) FALSE POSITIVE PATIENT SAMPLE CALLS: TWO (2) SAMPLES IN DATA FILE (B)(6) CONTAINED AIR BUBBLES IN THE WELLS CAUSING NON-SPECIFIC AMPLIFICATION THAT CROSSED THE THRESHOLD AND CAUSED TOTAL OF TWO (2) FALSE POSITIVE CLINICAL CALLS. > THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED AS IMPROPER CENTRIFUGATION OF THE QPCR PLATE TO RELEASE THE TRAPPED AIR BUBBLES. THREE (3) SAMPLES IN DATA FILE (B)(6) CONTAINED AIR BUBBLES IN THE WELLS CAUSING NON-SPECIFIC AMPLIFICATION THAT CROSSED THE THRESHOLD AND CAUSED TOTAL OF THREE (3) FALSE POSITIVE CLINICAL CALLS > THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED AS IMPROPER CENTRIFUGATION OF THE QPCR PLATE TO RELEASE THE TRAPPED AIR BUBBLES.

    Description of Event or Problem · 1

    USER ERROR IN PLATE MIXING CAUSED ERRONEOUS FALSE POSITIVE RESULTS. THE CUSTOMER REPORTED SEEING MULTIPLE WELLS APPEARING WITH BOTH FLAT AREAS AND JUMPS IN THE REACTION CURVE DATA DUE TO BUBBLES. ANALYSIS OF THE CUSTOMER'S DATA BY THERMO FISHER SCIENTIFIC'S TECHNICAL AND FIELD APPLICATION SCIENTIST TEAM REVEALED ISSUES WITH POOR CENTRIFUGATION OF THE QPCR PLATES AND 5 FALSE POSITIVE RESULTS.THE CUSTOMER INDICATED "WE WERE NOT VORTEXING/CENTRIFUGING THE PLATE UNTIL YOU (THERMO FISHER SCIENTIFIC) MENTIONED IT ON THE PHONE. WE WILL NOW START ADAPTING THAT TO OUR SOP." THE CUSTOMER DID NOT REPORT ANY DEATHS OR SERIOUS INJURIES TO THERMO FISHER SCIENTIFIC. THERMO FISHER WAS NOT ABLE TO CONFIRM WHETHER OR NOT THE FALSE POSITIVE RESULTS WERE REPORTED TO PHYSICIANS/PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031697 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) 2005122

    Patients

    Seq Age Sex Outcome Treatment
    1