BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3093833 · Received May 6, 2013

    Report

    Report Number
    2432235-2013-00166
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST DID NOT FIND AN INSTRUMENT MALFUNCTION. THE TSC SPECIALIST OFFERED FOR A FIELD SERVICE ENGINEER TO BE SENT TO THE CUSTOMER SITE, AND THE CUSTOMER DECLINED SERVICE. THE CUSTOMER EXPRESSED THAT THE SAMPLE APPEARED TO HAVE FIBRIN. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT ON ONE PATIENT SAMPLE 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 DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S) BECAUSE IT DID NOT MATCH THE PATIENT'S RESULTS FROM A PREVIOUS RUN ON AN ALTERNATE INSTRUMENT. THE SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND RESULTED LOWER. A RESULT FROM THE ALTERNATE INSTRUMENT WAS 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
    196611 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1