BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 2250109 · Received September 15, 2011

    Report

    Report Number
    2432235-2011-00129
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 25, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K032525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SOLUTIONS CENTER SPECIALIST CONTACTED THE CUSTOMER AND THE CUSTOMER DECLINED SERVICE. THE CAUSE OF THE DISCORDANT TNI UL RESULT IS UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT TROPONIN (TNI UL) RESULT WAS OBTAINED ON THE ADVIA CENTAUR INSTRUMENT. THE LABORATORY RAN THE SAMPLES IN DUPLICATE AND ONLY THE CORRECT RESULT WAS REPORTED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT TROPONIN RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1