BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3131857 · Received May 29, 2013

    Report

    Report Number
    2432235-2013-00188
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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 RESULTS WAS UNKNOWN. THE FSE PERFORMED A TOTAL SERVICE CALL, REVIEWED THE INSTRUMENT ERROR LOGS, VERIFIED THAT QC WAS ACCEPTABLE AND CONCLUDED THAT THERE WAS NO APPARENT MALFUNCTION DURING THE TIME OF THE EVENT. 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 MULTIPLE PATIENT SAMPLES ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED TWO TIMES AFTER THE INITIAL RESULTS WERE OBTAINED. THE SECOND REPEAT RESULT WAS THE CORRECTED RESULT, REPORTED TO THE PHYSICIAN(S). THERE IS NO REPORT OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TESTOSTERONE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237145 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1