BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 2930606 · Received January 28, 2013

    Report

    Report Number
    2432235-2013-00030
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 31, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE PERFORMED A TOTAL SERVICE CALL. THE FSE DID NOT FIND AN INSTRUMENT MALFUNCTION. THE CUSTOMER RAN QUALITY CONTROLS, ALL OF WHICH WERE WITHIN RANGE, AND PATIENT SAMPLES, WHICH WERE ACCURATE. THE CAUSE OF THE DISCORDANT HCG RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    ONE DISCORDANT, FALSELY LOW HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS RERUN TWICE ON A DIFFERENT INSTRUMENT, AND THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37061 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER DHA SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1