BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAQPATH COVID-19 COMBO KIT

    MDR report key: 12148059 · Received July 9, 2021

    Report

    Report Number
    3009976420-2021-00025
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 10, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING REVIEW OF THE TWO (2) CUSTOMER SUPPLIED DATA FILES, THERMO FISHER SCIENTIFIC IDENTIFIED ONE (1) FALSE POSITIVE (FP) 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 CENTRIFUGATION OF THE QPCR PLATE. CUSTOMER WAS ADVISED TO ENSURE THAT CENTRIFUGATION PARAMETERS ARE FOLLOWED PER PAGE 40 OF THE IFU (MAN0019181, REV. J) TO HELP AVOID RECURRENCE OF THE ISSUE. CORRECTION 11/04/2021. THERMO FISHER SCIENTIFIC TECHNICAL SUPPORT RECEIVED INFORMATION THAT THE ASSAY LOT NUMBER PROVIDED IN THE INITIAL MDR (211235) WAS INCORRECT. THE CORRECT LOT NUMBER IS 2102335 AND WAS UPDATED ACCORDINGLY VIA THIS MDR FOLLOW-UP #1.

    Description of Event or Problem · 0

    ON JUNE 11, 2021 THE CUSTOMER REPORTED ONE (1) SUSPECTED FALSE POSITIVE WHILE RUNNING THE TAQPATH¿ COVID-19 COMBO KIT ON A QUANT STUDIO 5 PCR INSTRUMENT. THE CUSTOMER REPORTED THAT THE PATIENT TESTED POSITIVE ON (B)(6) 2021 AND UPON RETEST USING A NEW SAMPLE FROM THE SAME PATIENT ON (B)(6) 2021, THE RESULTS WERE NEGATIVE. THERMO FISHER WAS ABLE TO CONFIRM THAT THE INITIAL RESULT WAS REPORTED TO THE PATIENT. THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURIES OR DEATH.

    Additional Manufacturer Narrative · 1

    DURING REVIEW OF THE TWO (2) CUSTOMER SUPPLIED DATA FILES, THERMO FISHER SCIENTIFIC IDENTIFIED ONE (1) FALSE POSITIVE (FP) 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 CENTRIFUGATION OF THE QPCR PLATE. CUSTOMER WAS ADVISED TO ENSURE THAT 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

    ON (B)(6) 2021 THE CUSTOMER REPORTED ONE (1) SUSPECTED FALSE POSITIVE WHILE RUNNING THE TAQPATH" COVID-19 COMBO KIT ON A QUANT STUDIO 5 PCR INSTRUMENT. THE CUSTOMER REPORTED THAT THE PATIENT TESTED POSITIVE ON (B)(6) 2021 AND UPON RETEST USING A NEW SAMPLE FROM THE SAME PATIENT ON (B)(6) 2021, THE RESULTS WERE NEGATIVE. THERMO FISHER WAS ABLE TO CONFIRM THAT THE RESULTS WERE REPORTED OUT TO THE PATIENT. THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURIES OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043048 TAQPATH COVID-19 COMBO KIT TAQPATH¿ COVID-19 COMBO KIT QJR LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) 2102335

    Patients

    Seq Age Sex Outcome Treatment
    1