BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HBSAG ASSAY

    MDR report key: 1593662 · Received February 1, 2010

    Report

    Report Number
    1219913-2010-00013
    Event Type
    Other
    Date Received
    February 1, 2010
    Date of Event
    January 2, 2010
    Report Date
    January 21, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR (B)(6) RESULT WITH OTHER METHODS IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) LIMITATION SECTION STATES: "IT IS RECOGNIZED THAT THE CURRENT METHODS FOR THE DETECTION OF (B)(6) SURFACE ANTIGEN MAY NOT DETECT ALL POTENTIALLY INFECTED INDIVIDUALS. A NONREACTIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH (B)(6). A NONREACTIVE TEST RESULT IN INDIVIDUALS WITH PRIOR EXPOSURE TO (B)(6) MAY BE DUE TO ANTIGEN LEVELS BELOW THE DETECTION LIMIT OF THIS ASSAY OR LACK OF ANTIGEN REACTIVITY TO THE ANTIBODIES IN THIS ASSAY." THE CUSTOMER DECLINED SERVICE - NO FURTHER ACTION TAKEN.

    Description of Event or Problem · 1

    A NEGATIVE ADVIA CENTAUR XP (B)(6) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE NEGATIVE RESULT DID NOT MATCH THE POSITIVE RESULT OBTAINED BY ANOTHER METHOD. THE PHYSICIAN QUESTIONED THE NEGATIVE RESULT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 145

    Patients

    Seq Age Sex Outcome Treatment
    1