BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 930386 · Received October 19, 2007

    Report

    Report Number
    2432235-2007-00039
    Event Type
    Other
    Date Received
    October 19, 2007
    Date of Event
    May 4, 2007
    Report Date
    August 29, 2007
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESERVED PATIENT SAMPLES WERE RETESTED WITH A DIFFERENT KIT OF TNI-ULTRA ON A DIFFERENT ADVIA CENTAUR XP INSTRUMENT AND THE REPEAT TESTING CONFIRMED THE FALSE HIGH RESULTS. SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS HAS ISSUED TWO CUSTOMER BULLETINS TO PROVIDE MORE INFORMATION AND INSTRUCTION TO CUSTOMERS REGARDING THIS TROPONIN ULTRA ISSUE. ADDITIONALLY, A RESOLUTION FOR THIS ISSUE HAS BEEN IDENTIFIED AND BECAME AVAILABLE IN OCTOBER, 2007.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT IN 2007, A PATIENT SAMPLE TESTED POSITIVE FOR TROPONIN ON THE ADVIA CENTAUR TNI-ULTRA ASSAY. THE PATIENT SAMPLE WAS RETESTED THE NEXT DAY, ON THE ADVIA CENTAUR TNI-ULTRA AND THE SAMPLE TESTED POSITIVE FOR TROPONIN AGAIN. THE NEXT MONTH, A CARDIAC CATHETERIZATION PERFORMED WITH FINDINGS OF MODERATE LEFT MAIN CORONARY VESSEL DISEASE, MODERATE RIGHT PROXIMAL RIGHT CORONARY DISEASE, NORMAL LEFT VENTRICULAR FUNCTION AND THE ABSENCE OF PULMONARY EMBOLI. THE ELEVATED TROPONIN RESULTS CONTRIBUTED TO THE DECISION TO CONDUCT THE CARDIAC CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 012

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other