BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 2122922 · Received June 14, 2011

    Report

    Report Number
    2432235-2011-00085
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 15, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K902336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. INSPECTION OF THE SYSTEM REVEALED A BUILD UP OF A WHITE PRECIPITATE AROUND THE PUMP 2 AND WD (WASH DISPLACEMENT) PORTS ON THE VALVE MANIFOLD. THE FSE REPLACED THE VALVE MANIFOLD AND RAN QC. THE INSTRUMENT HAS BEEN REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. INSPECTION OF THE SYSTEM REVEALED A BUILD UP OF A WHITE PRECIPITATE AROUND THE PUMP 2 AND WD (WASH DISPLACEMENT) PORTS ON THE VALVE MANIFOLD. THE FSE REPLACED THE VALVE MANIFOLD AND RAN QC. THE INSTRUMENT HAS BEEN REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT TROPONIN (TNI) RESULTS WERE OBTAINED ON THE ADVIA CENTAUR CP INSTRUMENT. THE LABORATORY RETESTED THE SAMPLES AND CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT TROPONIN RESULTS.

    Description of Event or Problem · 1

    DISCORDANT TROPONIN (TNI) RESULTS WERE OBTAINED ON THE ADVIA CENTAUR CP INSTRUMENT. THE LABORATORY RETESTED THE SAMPLES AND CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT TROPONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CP IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP N/A

    Patients

    Seq Age Sex Outcome Treatment
    1