BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3061973 · Received April 16, 2013

    Report

    Report Number
    2432235-2013-00139
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 ASPIRATE PROBE 1 WAS PLUGGED. THE FSE REPLACED ASPIRATE PROBE 1. THE FSE THEN PROACTIVELY REPLACED ITS ASSOCIATED FITTINGS AND TUBING, THE PINCH VALVE AND PINCH VALVE TUBING, AND THE ASPIRATE WASH BLOCKS. QUALITY CONTROLS WERE THEN RUN, AND ALL WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT RESULTS WAS THE PLUGGED ASPIRATE PROBE 1. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ALPHA-FETOPROTEIN (AFP) RESULTS AND A DISCORDANT TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WERE OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE RERUN ON AN ALTERNATE INSTRUMENT, AND THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP AND THCG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163428 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1