BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 1810737 · Received August 12, 2010

    Report

    Report Number
    1219913-2010-00091
    Event Type
    Other
    Date Received
    August 12, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR TROPONIN ULTRA RESULTS WERE OBTAINED FOR A PATIENT SAMPLES. THE NEAT AND DILUTED RESULTS DID NOT MATCH. PATIENT 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 TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 045

    Patients

    Seq Age Sex Outcome Treatment
    1