BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3090843 · Received May 2, 2013

    Report

    Report Number
    2432235-2013-00161
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DID NOT FIND AN INSTRUMENT MALFUNCTION. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT IS UNKNOWN. 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 ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE SAMPLE HAD BEEN RUN IN DUPLICATE, AND THE RESULTS DID NOT MATCH. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN IN DUPLICATE ON AN ALTERNATE ADVIA CENTAUR XP INSTRUMENT, AND THE RESULTS MATCHED THE LOWER RESULT FROM THE INITIAL RUN. 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
    191433 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1