BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 12197778 · Received July 20, 2021

    Report

    Report Number
    3009976420-2021-00026
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    May 27, 2021
    Report Date
    November 4, 2021
    Manufacturer
    LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING REVIEW OF THE FIVE (5) CUSTOMER SUPPLIED DATA FILES, THERMO FISHER SCIENTIFIC IDENTIFIED ONE (1) FALSE POSITIVE RESULT WHICH WAS ATTRIBUTED TO SIGNAL DISCONTINUITY THAT MIMICS REAL AMPLIFICATION, A PATTERN THAT IS GENERALLY CAUSED BY A BUBBLE. THE BUBBLE RESULTED IN NON-SPECIFIC AMPLIFICATION DURING PCR THERMOCYCLING THAT CROSSED THE THRESHOLD AND CAUSED A FALSE POSITIVE RESULT. THE AIR BUBBLES WERE LIKELY CAUSED BY INADEQUATE VORTEXING AND/OR CENTRIFUGATION OF THE QPCR PLATE. THE CUSTOMER WAS ADVISED TO ENSURE THAT VORTEXING AND CENTRIFUGATION PARAMETERS ARE FOLLOWED PER PAGE 40 OF THE IFU (MAN0019181, REV. J) TO HELP AVOID RECURRENCE OF THE ISSUE. UPDATE 10/26/2021: ON THE SAME DAY THAT THE INITIAL MDR WAS SUBMITTED (07/20/2021), THERMO FISHER SCIENTIFIC RECEIVED CONFIRMATION FROM THE CUSTOMER THAT THE FALSE POSITIVE RESULT (1) WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DETECTED THE PROBLEM AND RE-RAN ANY SUSPECTED SAMPLES PRIOR TO REPORTING OUT. THIS MDR WAS UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    CUSTOMER'S IMPROPER VORTEXING AND/OR CENTRIFUGATION OF THE QPCR PLATE MAY HAVE LED TO ONE (1) IDENTIFIED FALSE POSITIVE PATIENT RESULT WHILE RUNNING THE TAQPATH¿ COVID-19 COMBO KIT. THE ISSUE WAS IDENTIFIED BY THERMO FISHER SCIENTIFIC DURING DATA FILE REVIEW ON JUNE 21, 2021. THE CUSTOMER WAS USING AN APPLIED BIOSYSTEMS¿ 7500 FAST INSTRUMENT. THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURIES OR DEATH. THERMO FISHER CONFIRMED ON 07/20/2021 THAT THE FALSE RESULT WAS DETECTED BY THE CUSTOMER AND AS SUCH WAS NOT REPORTED TO THE PHYSICIAN AND/OR PATIENT.

    Additional Manufacturer Narrative · 1

    DURING REVIEW OF THE FIVE (5) CUSTOMER SUPPLIED DATA FILES, THERMO FISHER SCIENTIFIC IDENTIFIED ONE (1) FALSE POSITIVE RESULT WHICH WAS ATTRIBUTED TO SIGNAL DISCONTINUITY THAT MIMICS REAL AMPLIFICATION, A PATTERN THAT IS GENERALLY CAUSED BY A BUBBLE. THE BUBBLE RESULTED IN NON-SPECIFIC AMPLIFICATION DURING PCR THERMOCYCLING THAT CROSSED THE THRESHOLD AND CAUSED A FALSE POSITIVE RESULT. THE AIR BUBBLES WERE LIKELY CAUSED BY INADEQUATE VORTEXING AND/OR CENTRIFUGATION OF THE QPCR PLATE. THE CUSTOMER WAS ADVISED TO ENSURE THAT VORTEXING AND CENTRIFUGATION PARAMETERS ARE FOLLOWED PER PAGE 40 OF THE IFU (MAN0019181, REV. J) TO HELP AVOID RECURRENCE OF THE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER'S IMPROPER VORTEXING AND/OR CENTRIFUGATION OF THE QPCR PLATE MAY HAVE LED TO ONE (1) IDENTIFIED FALSE POSITIVE PATIENT RESULT WHILE RUNNING THE TAQPATH¿ COVID-19 COMBO KIT. THE ISSUE WAS IDENTIFIED BY THERMO FISHER SCIENTIFIC DURING DATA FILE REVIEW ON JUNE21, 2021. THE CUSTOMER WAS USING AN APPLIED BIOSYSTEMS¿ 7500 FAST INSTRUMENT. THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURIES OR DEATH. THERMO FISHER WAS NOT ABLE TO CONFIRM WHETHER THE FALSE RESULT WAS REPORTED TO THE PHYSICIAN AND/OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091762 TAQPATH COVID-19 COMBO KIT TAQPATH¿ COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) 2009246

    Patients

    Seq Age Sex Outcome Treatment
    1