BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID19 COMBO KIT

    MDR report key: 11638486 · Received April 8, 2021

    Report

    Report Number
    3009976420-2021-00017
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 9, 2021
    Report Date
    May 7, 2021
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REVIEW OF THE TWO DATA FILES PROVIDED BY THE CUSTOMER, THERMO FISHER SCIENTIFIC CONFIRMED THREE (3) FALSE POSITIVE RESULTS OUT OF (B)(6) SAMPLES. THE FALSE POSITIVE RESULTS WERE ATTRIBUTED TO THE PRESENCE OF AIR BUBBLES IN THREE REACTION WELLS (A1, A5 AND B5), WHICH RESULTED IN NON-SPECIFIC AMPLIFICATION THAT CROSSED THE THRESHOLD DURING THERMOCYCLING IN PCR. THERMO FISHER SCIENTIFIED ADVISED THE CUSTOMER TO REVIEW THEIR DATA FILES FOR THE PRESENCE OF AIR BUBBLES IN THE REACTION WELLS TO HELP PREVENT RECURRENCE OF THIS ISSUE.

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS BEEN UNRESPONSIVE TO MULTIPLE REQUESTS FOR SOFTWARE DATA FILES TO COMPLETE OUR INVESTIGATION. NO ROOT CAUSE COULD BE DETERMINED. THERMO FISHER SCIENTIFIC WILL PROVIDE ADDITIONAL INFORMATION, INCLUDING ANY FALSE RESULTS IDENTIFIED DURING DATA FILE REVIEW, VIA A FOLLOW-UP MDR..

    Description of Event or Problem · 1

    ON (B)(6) 2021 THERMO FISHER SCIENTIFIC WAS NOTIFIED OF SUSPECTED FALSE POSITIVE RESULTS BY THE CUSTOMER WHILE RUNNING THE RUO LABELED TAQPATH¿ COVID19 COMBO KIT, WHILE USING RUO WORKFLOW AND RUO HARDWARE/COMPONENTS. SUBSEQUENT ANALYSIS ON ANOTHER PLATNFORM SHOWED THESE RESULTS TO BE NEGATIVE. THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURIES OR DEATH. THERMO FISHER WAS NOT ABLE TO CONFIRM WHETHER OR NOT THE FALSE RESULTS WERE REPORTED TO THE PHYSICIAN AND/OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533021 TAQPATH COVID19 COMBO KIT TAQPATH¿ COVID19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)

    Patients

    Seq Age Sex Outcome Treatment
    1