BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 2860875 · Received December 6, 2012

    Report

    Report Number
    2432235-2012-00432
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CDD
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND DETERMINED THE CAUSE OF THE DISCORDANT RESULTS WAS A MALFUNCTION OF THE WASTE PUMP. THE FSE REPLACED THE PUMP, THE WASTE RESERVOIR SENSOR, AND THE REAGENT PROBE 1 HEATER COIL. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS FOR VITAMIN D AND OTHER ASSAYS WERE OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIANS. THE CUSTOMER SENT ALL THE SAMPLES TO ANOTHER LABORATORY AND OBTAINED DIFFERENT RESULTS. CORRECTED RESULT REPORTS WERE SENT TO THE PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1