BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HBSAG ASSAY

    MDR report key: 1582904 · Received January 19, 2010

    Report

    Report Number
    1219913-2010-00009
    Event Type
    Other
    Date Received
    January 19, 2010
    Date of Event
    January 11, 2010
    Report Date
    January 13, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE CUSTOMER SENT THE PATIENT SAMPLE TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING. THE RESULT WAS POSITIVE FOR HBSAG BY AN ALTERNATE METHOD AND THEREFORE INDICATES THE PRESENCE OF A MUTATION. THE IFU (0341888 REV. K, 2009-02) STATES IN THE LIMITATIONS SECTION: "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 HEPATITIS B. A NONREACTIVE TEST RESULT IN INDIVIDUALS WITH PRIOR EXPOSURE TO HEPATITIS B MAY BE DUE TO ANTIGEN LEVELS BELOW THE DETECTION LIMIT OF THIS ASSAY OR LACK OF ANTIGEN REACTIVITY TO THE ANTIBODIES IN THIS ASSAY."

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP (B)(6) RESULT WITH OTHER METHODS IS UNKNOWN. THE INSTRUCTION FOR USE (IFU) LIMITATION CLAIM 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 PERFORMANCE OF THE ASSAY HAS NOT BEEN ESTABLISHED FOR POPULATIONS OF IMMUNOCOMPROMISED OR IMMUNOSUPPRESSED PATIENTS. RESULTS FROM THESE INDIVIDUALS MUST BE INTERPRETED WITH CAUTION." NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    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 RESULTS OBTAINED BY THREE OTHER METHODS. 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 144

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR