BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 3090844 · Received May 2, 2013

    Report

    Report Number
    2432235-2013-00162
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 A LEAK UNDER THE BASE PUMP. THE FSE REPAIRED THE LEAKING BASE PUMP AND THE ACID PUMP PISTON, WHICH HAD SIGNS OF OXIDATION. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT WAS A MALFUNCTION OF THE BASE PUMP. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED TROPONIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR CP INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN IN DUPLICATE ON THE SAME INSTRUMENT, AND RESULTED LOWER. 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 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192352 ADVIA CENTAUR CP IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR CP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR