BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 1220556 · Received October 30, 2008

    Report

    Report Number
    1219913-2008-00085
    Event Type
    Other
    Date Received
    October 30, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 30, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT DATE INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT IS UNK. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    SEVERAL POSITIVE ADVIA CENTAUR TROPONIN ULTRA PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. THE CUSTOMER RAN THE PATIENT SAMPLES ON A DIFFERENT SYSTEM USING THE SAME REAGENT LOT AND THEY OBTAINED DIFFERENT RESULTS. A CORRECTED REPORT WAS SENT TO THE PHYSICIAN. ONE PATIENT WAS ADMITTED TO THE HOSPITAL, DUE TO THE FALSELY ELEVATED TROPONIN ULTRA RESULT. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 28

    Patients

    Seq Age Sex Outcome Treatment
    1