BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP HBC TOTAL (HBCT)

    MDR report key: 1713301 · Received June 2, 2010

    Report

    Report Number
    1219913-2010-00062
    Event Type
    Other
    Date Received
    June 2, 2010
    Date of Event
    March 15, 2010
    Report Date
    May 21, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P040004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) TOTAL RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. 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 (B)(6) TOTAL ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAY FOR SPECIFIC (B)(6) SEROLOGICAL MARKERS."

    Description of Event or Problem · 1

    A PATIENT SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP FOR THE (B)(6) TOTAL ASSAY AS PART OF A CORRELATION STUDY WITH THE ABBOTT ARCHITECT. THE PT SAMPLE RESULTS WERE NEGATIVE ON THE ADVIA CENTAUR XP AND POSITIVE ON THE ABBOTT ARCHITECT. THE PT IS A CONFIRMED ACUTE (B)(6) PATIENT. THE RESULTS FROM THE ADVIA CENTAUR XP WERE NOT REPORTED. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) TOTAL RESULTS.

    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 51 YR