BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3011955 · Received March 20, 2013

    Report

    Report Number
    2432235-2013-00092
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DLZ
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND DETERMINED THE CAUSE OF THE DISCORDANT PHENOBARBITAL RESULT WAS UNKNOWN. THE FSE CHECKED THE PROBE TO CUVETTE CALIBRATION AND CHECKED THE SAMPLE AND ANCILLARY PROBES. THE FSE REPLACED A VERTICAL GUIDE ROD ON REAGENT PROBE 1 AND SUCCESSFULLY RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT PHENOBARBITAL RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT PHENOBARBITAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PHENOBARBITAL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116478 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER DLZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1