BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 1897565 · Received November 8, 2010

    Report

    Report Number
    1219913-2010-00132
    Event Type
    Other
    Date Received
    November 8, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    SIEMENS HEATLHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULTS MAYBE DUE TO FIBRIN CLOTS OR STRINGS IN THE SAMPLE. THE CUSTOMER OBSERVED THAT THEIR SAMPLE TUBES, GEL BARRIER, LOOKED AS IF IT WAS LEAVING FIBRIN CLOTS OR STRINGS SOMETIMES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA RESULTS WERE OBTAINED FOR TWO PT SAMPLES. THE RESULTS WERE QUESTIONED. TESTING WAS REPEATED FOR THE PT SAMPLES. THE RESULTS WERE NEGATIVE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEATLHCARE DIAGNOSTICS INC. NA 044

    Patients

    Seq Age Sex Outcome Treatment
    1