BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 1781421 · Received July 28, 2010

    Report

    Report Number
    2432235-2010-00109
    Event Type
    Other
    Date Received
    July 28, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 7, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K902336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. BASED UPON THE INFO PROVIDED AND AN EVAL OF THE INSTRUMENT, IT IS UNK WHAT CAUSED THE DISCORDANT TROPONIN ULTRA RESULT. THE FSE PERFORMED PREVENTATIVE MAINTENANCE AND LUBRICATION OF SAMPLE PROBE. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ADVIA CENTAUR CP TROPONIN ULTRA RESULT WAS OBTAINED ON A PT SAMPLE. THE PT WAS HOSPITALIZED AND THE TEST WAS REPEATED ON BOTH AN ADVIA CENTAUR CP AND ADVIA CENTAUR XP SYSTEM. THE REPEAT TROPONIN ULTRA RESULTS WERE NEGATIVE. NO TREATMENT WAS GIVEN TO THE PT DUE TO THE HIGH RESULT. 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 IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR CP NA

    Patients

    Seq Age Sex Outcome Treatment
    1