BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HBSAG (HBS) ASSAY

    MDR report key: 1338186 · Received March 6, 2009

    Report

    Report Number
    1219913-2009-00026
    Event Type
    Other
    Date Received
    March 6, 2009
    Date of Event
    February 11, 2009
    Report Date
    February 17, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE IS UNAVAILABLE FOR FURTHER EVALUATION. THE CAUSE FOR THE DISCORDANT HBSAG RESULT IS UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR HBSAG RESULT WAS OBTAINED ON A PATIENT SAMPLE AND WAS CONFIRMED. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT. THE PATIENT SAMPLE WAS RETESTED IN DUPLICATE. THE RESULTS WERE NONREACTIVE. THE PT WAS REDRAWN AND THE SAMPLE TESTED. THE RESULT WAS NONREACTIVE AND A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HBSAG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR HBSAG (HBS) ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 140

    Patients

    Seq Age Sex Outcome Treatment
    1