BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP HBC TOTAL (HBCT)

    MDR report key: 1669097 · Received April 23, 2010

    Report

    Report Number
    1219913-2010-00048
    Event Type
    Other
    Date Received
    April 23, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 9, 2010
    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

    THE CAUSE FOR THE FALSE (B)(6) HBC TOTAL RESULT IS UNK. A SIEMENS REP EXAMINED THE HBC TOTAL QC AND CALIBRATIONS. NO ISSUES WERE FOUND. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR HBC TOTAL ASSAY IS USED IN CONJUNCTION WITH OTHER MFR'S ASSAY FOR SPECIFIC HBV SEROLOGICAL MARKERS."

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR XP HBC TOTAL RESULT WAS OBTAINED ON A PT SAMPLE. THE PT SAMPLE WAS TESTED FOR ANTI-HBE AND ANTI-HBS AND THE RESULTS WERE (B)(6) WHICH SEEMED TO INDICATE THAT THE HBC TOTAL RESULT WAS FALSE (B)(6). THE PT SAMPLE WAS TESTED ON AN ALTERNATE METHOD FOR HBC TOTAL AND THE RESULT WAS (B)(6). PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HBC TOTAL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HBC TOTAL (HBCT) HBCT IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1