BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 3100874 · Received May 8, 2013

    Report

    Report Number
    2432235-2013-00168
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 9, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SERVICE CONSULTANT (TSC) WAS CONTACTED BY THE CUSTOMER. THE TSC EVALUATED THE INSTRUMENT DATA AND DETERMINED THE CAUSE OF THE DISCORDANT TNI UL RESULTS WAS UNKNOWN. THE CUSTOMER DECLINED SERVICE. THE TSC DETERMINED THERE WAS NO INDICATION OF A SYSTEM MALFUNCTION DURING THE TIME OF THE EVENT. THE SYSTEM IS RUNNING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS NECESSARY.

    Description of Event or Problem · 1

    THE CUSTOMER WAS USING TWO LOTS OF TROPONIN ULTRA (TNI UL) AND PLACED LOT 71 MATERIAL INTO A TUBE LABELED FOR LOT 70. DISCORDANT RESULTS WERE OBTAINED ON AN ADVIA CENTAUR FOR TROPONIN ULTRA (TNI UL) ON EIGHT PATIENTS. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER RERAN THE SAME SAMPLES ON THE SAME INSTRUMENT AND THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT TNI UL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201409 ADVIA CENTAUR IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1