BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3000412 · Received March 12, 2013

    Report

    Report Number
    2432235-2013-00087
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 12, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED THAT THE WASTE RESERVOIR CAP WAS PLUGGED, PREVENTING THE VACUUM AT THE WASTE RESERVOIR FROM WORKING PROPERLY. THE FSE CLEARED THE PLUGGED WASTE RESERVOIR CAP, AND THE VACUUM BEGAN TO FUNCTION PROPERLY. THE FSE RAN CALIBRATION AND QUALITY CONTROLS, WHICH WERE WITHIN RANGE, AND OBSERVED PATIENT SAMPLES BEING RUN, WHICH RESULTED WITHOUT ERROR. THE CAUSE OF THE DISCORDANT CEA AND TESTOSTERONE RESULTS WAS THE PLUGGED WASTE RESERVOIR CAP. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE AND DISCORDANT, FALSELY LOW TESTOSTERONE RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN, AND THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT WITH A FALSELY ELEVATED CEA RESULT WAS SENT FOR A COMPUTED TOMOGRAPHY SCAN AND FURTHER LABORATORY TESTING WAS PERFORMED. ONE OF THE PATIENTS WITH FALSELY LOW TESTOSTERONE RESULT RECEIVED A TESTOSTERONE INJECTION. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CEA AND TESTOSTERONE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102993 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1