BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 2823789 · Received July 10, 2008

    Report

    Report Number
    1219913-2008-00054
    Event Type
    Other
    Date Received
    July 10, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 16, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER RUNS ALL ADVIA CENTAUR CP TROPONIN ULTRA PT SAMPLES IN DUPLICATE. A POSITIVE AND A NEGATIVE TROPONIN ULTRA RESULT WAS OBTAINED ON A PT SAMPLE. WHEN THE PT SAMPLE WAS RETESTED, THE TROPONIN ULTRA RESULTS WERE NEGATIVE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. 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 CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1