BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HBC TOTAL (HBCT) ASSAY

    MDR report key: 3021337 · Received March 26, 2013

    Report

    Report Number
    1219913-2013-00072
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 6, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P040004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP (B)(6) TOTAL RESULT IS UNKNOWN. A PATIENT SAMPLE IS UNAVAILABLE FOR FURTHER INVESTIGATION. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. THE INSTRUCTIONS FOR USE (IFU) STATES IN THE INTENDED USE SECTION: "THE ADVIA CENTAUR HBC TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE CORE ANTIGEN OF THE ((B)(6) TOTAL) IN HUMAN SERUM OR EDTA PLASMA USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THIS ASSAY CAN BE USED AS AN AID IN THE DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR (B)(6) INFECTION AND IN THE DETERMINATION OF THE CLINICAL STATUS OF (B)(6) INFECTED INDIVIDUALS IN CONJUNCTION WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF (B)(6) DISEASE ASSOCIATED WITH (B)(6) INFECTION." THE IFU STATES IN THE LIMITATIONS SECTION: "THE ADVIA CENTAUR (B)(4) 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 ANTI-HBC 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."

    Description of Event or Problem · 1

    A (B)(4) ADVIA CENTAUR XP (B)(6) TOTAL RESULT WAS OBTAINED ON A PATIENT SAMPLE AND QUESTIONED BY THE PHYSICIAN. THE NEGATIVE PATIENT SAMPLE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT SAMPLE TEST RESULTS AND A REDRAW SAMPLE TEST RESULT. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP (B)(6) TOTAL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123580 ADVIA CENTAUR XP HBC TOTAL (HBCT) ASSAY HBCT IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 052

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR