BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVIA CENTAUR

    MDR report key: 2213389 · Received August 16, 2011

    Report

    Report Number
    2432235-2011-00112
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 29, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT AND INSTRUMENT DATA. AFTER ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA, IT WAS DETERMINED THAT THE CAUSE OF THE DISCORDANT TROPONIN AND CKMB RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HIGH ADVIA CENTAUR TROPONIN AND CKMB RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES. THE LABORATORY REPEATED THE SAMPLES AND CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN(S). ONE PATIENT WAS CATHETERIZED DUE TO THE DISCORDANT TROPONIN AND CKMB RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR DIAGNOSTICS AUTOMATED CHEMILUMINECSENSE SYSTEM (ACS) CENTAUR ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization