BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR XP HBC TOTAL (HBCT)

    MDR report key: 2103334 · Received May 26, 2011

    Report

    Report Number
    1219913-2011-00080
    Date Received
    May 26, 2011
    Date of Event
    November 19, 2010
    Report Date
    May 9, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P040004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO KNOWN SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT ADVIA CENTAUR XP HBCT TEST RESULTS. THE LIMITATION SECTION OF THE IFU STATES THE FOLLOWING: "THE ADVIA CENTAUR HBC TOTAL ASSAY IS LIMITED TO THE DETECTION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN IN HUMAN SERUM OR EDTA PLASMA. ASSAYS FOR THE DETECTION OF ANTI-HBC MAY NOT IDENTIFY ALL PATIENT SAMPLES THAT CONTAIN HEPATITIS B VIRUS OR POTENTIALLY INFECTIOUS UNITS OF BLOOD AND MAY GENERATE FALSE REACTIVE RESULTS." NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    (B)(6) ADVIA CENTAUR XP HBC TOTAL RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES AND DISCORDANT WHEN COMPARED TO ANOTHER HBC TOTAL TEST METHOD. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HBC TOTAL TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HBC TOTAL (HBCT) HBCT IMMUNOASAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A REF B6

    Patients

    Seq Age Sex Outcome Treatment
    1