BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3183188 · Received June 21, 2013

    Report

    Report Number
    2432235-2013-00286
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 27, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO ANALYZE THE INSTRUMENT AND INSTRUMENT DATA. THE FSE DETERMINED THAT THE CAUSE FOR THE DISCORDANT TESTOSTERONE RESULT WAS DUE TO AN OBSTRUCTION IN THE ASPIRATE PROBE 2 NEEDLE. THE FSE CLEANED THE WASH STATION, REPLACED THE NEEDLE AND RAN CALIBRATIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT TESTOSTERONE RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED AND THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN. THERE IS NO REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TESTOSTERONE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283872 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1