BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 3123008 · Received May 21, 2013

    Report

    Report Number
    2432235-2013-00182
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED THAT THE LUMINOMETER WAS INTERMITTENTLY GIVING HIGH DARK COUNTS. THE FSE REPLACED THE LUMINOMETER AND CHECKED THE DARK COUNTS, WHICH WERE WITHIN SPECIFICATIONS. THE FSE THEN CALIBRATED THE INSTRUMENT AND RAN QUALITY CONTROLS, ALL OF WHICH WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULTS WAS A MALFUNCTION OF THE LUMINOMETER. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED TROPONIN RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON AN ADVIA CENTAUR CP INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE RERUN ON THE SAME INSTRUMENT AND RESULTED LOWER. THE SAMPLES WERE THEN RERUN ON AN ALTERNATE INSTRUMENT, AND THE RESULTS MATCHED THE RERUN RESULTS FROM THE ADVIA CENTAUR CP. THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223607 ADVIA CENTAUR CP IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP

    Patients

    Seq Age Sex Outcome Treatment
    1