BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 3250949 · Received July 29, 2013

    Report

    Report Number
    2432235-2013-00366
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND DETERMINED THAT THE CAUSE OF THE DISCORDANT TNI RESULTS WAS UNKNOWN. THE FSE PROACTIVELY REPLACED THE ASPIRATE WASH BLOCK FOR PROBE 1 AND 2, AND CHECKED THE WASH SEQUENCE FOR TNI, THAT UTILIZES ALL FOUR ASPIRATION PROBES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HIGH RESULTS WERE OBTAINED FOR TROPONIN I (TNI) ON AN ADVIA CENTAUR CP INSTRUMENT FOR TWO PATIENTS. THE TNI RESULTS WERE REPORTED TO THE PHYSICIANS. THE FIRST PATIENT WAS REPEATED USING THE SAME SAMPLE AND THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THE SECOND PATIENT WAS REPEATED USING A NEW SAMPLE AND THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH TNI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353309 ADVIA CENTAUR CP IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP

    Patients

    Seq Age Sex Outcome Treatment
    1