BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR HBC TOTAL (HBCT)

    MDR report key: 2072485 · Received April 29, 2011

    Report

    Report Number
    1219913-2011-00060
    Date Received
    April 29, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 1, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P040004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON (B)(4), 2011.(B)(4) 2012: ADDITIONAL INFORMATION:BASED ON THE HBV SEROLOGICAL DATA PROVIDED BY THE CUSTOMER, IT APPEARS THIS PATIENT IS RECOVERED OR GOING INTO RECOVERY.THE INSTRUCTIONS FOR USE, DISTRIBUTED IN THE US, STATES IN THE PERCENT AGREEMENT SECTION FOR RECOVERED (B)(4).

    Additional Manufacturer Narrative · 1

    THERE ARE NO KNOWN SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT ADVIA CENTAUR (B)(6) TEST RESULTS. SYSTEM CALIBRATION AND QC WAS ACCEPTABLE. NO CONCLUSION CAN BE DRAWN. AS STATED IN THE IFU INTENDED USE (EX US) AND LIMITATION SECTIONS: " THE ADVIA CENTAUR HBC TOTAL ASSAY IS LIMITED TO THE DETECTION OF TOTAL ANTIBODIES TO (B)(6) CORE ANTIGEN IN HUMAN SERUM OR EDTA PLASMA. ASSAYS FOR THE DETECTION OF (B)(6) MAY NOT IDENTIFY ALL PATIENT SAMPLES THAT CONTAIN (B)(6) OR POTENTIALLY INFECTIOUS UNITS OF BLOOD AND MAY GENERATE FALSE REACTIVE RESULTS. " "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." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A NON REACTIVE ADVIA CENTAUR (B)(6) RESULT WAS OBTAINED BY THE CUSTOMER AND DISCORDANT WHEN COMPARED TO THE PATIENT'S CLINICAL PICTURE AND REPEAT TESTING ON ANOTHER (B)(6) TEST METHOD. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR HBC TOTAL (HBCT) HBCT IMMUNOASAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 037

    Patients

    Seq Age Sex Outcome Treatment
    1