BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 10557325 · Received September 18, 2020

    Report

    Report Number
    3009976420-2020-00022
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 21, 2020
    Report Date
    September 18, 2020
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING REVIEW OF THESE DATA FILES, THERMO FISHER SCIENTIFIC IDENTIFIED A SINGLE (1) FALSE POSITIVE PATIENT SAMPLE CALL. ONE (1) SAMPLE IN DATA FILE SARS081420THERMOP1_COPY.EDS CONTAINED AN AIR BUBBLE IN THE WELL THAT POPPED DURING PCR CYCLING, WHICH RESULTED IN NON-SPECIFIC AMPLIFICATION THAT CROSSED THE THRESHOLD AND CAUSED A TOTAL OF ONE (1) FALSE POSITIVE CLINICAL CALL. THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED AS IMPROPER CENTRIFUGATION OF THE QPCR PLATE TO RELEASE THE TRAPPED AIR BUBBLES. THE CUSTOMER WAS ADVISED TO REPLACE THEIR CENTRIFUGE WITH A MODEL CAPABLE OF BEING PROGRAMMED TO 650G.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POOR MS2 AMPLIFICATION AND RESULTS WERE SHOWING DISCREPANCIES, WITH ONE SUSPECTED FALSE POSITIVE PATIENT RESULT. THE CUSTOMER PROVIDED THERMO FISHER SCIENTIFIC WITH 6 DATA LOG FILES FROM 7500 SERIES INSTRUMENT ON 21-AUG-2020. ANALYSIS OF THE CUSTOMER'S DATA BY THERMO FISHER SCIENTIFIC'S TECHNICAL AND FIELD APPLICATION SCIENTISTS TEAMS REVEALED ISSUES WITH POOR CENTRIFUGATION AND USER ERROR WITH PIPETTING CAUSING POSSIBLE CONTAMINATION OF THE QPCR PLATES. THE CUSTOMER DID NOT REPORT ANY DEATHS OR SERIOUS INJURIES TO THERMO FISHER SCIENTIFIC. THERMO FISHER WAS NOT ABLE TO CONFIRM WHETHER OR NOT ANY FALSE RESULTS WERE REPORTED TO PHYSICIANS/PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016494 TAQPATH COVID-19 COMBO KIT TAQPATH COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) 2005131

    Patients

    Seq Age Sex Outcome Treatment
    1