BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 4183322 · Received October 17, 2014

    Report

    Report Number
    2432235-2014-00606
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REPLACED THE DILUTER 1, DILUTER 2 AND PHOTOMULTIPLIER TUBE ASSEMBLIES. THE CSE ALSO CALIBRATED ALL METHODS. THE CAUSE OF THE DISCORDANT TNIU RESULT IS UNKNOWN. THE CSE SUCCESSFULLY RAN QUALITY CONTROLS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (TNIU) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RE-SPUN AND TESTED THREE TIMES ON THE SAME SYSTEM, WHICH RESULTED LOWER. IT IS UNKNOWN AS TO WHICH REPEAT RESULT WAS THE CORRECTED RESULT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT TNIU RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660348 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1