BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HBC TOTAL (HBCT) ASSAY

    MDR report key: 2862213 · Received December 7, 2012

    Report

    Report Number
    1219913-2012-00408
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    October 8, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P40004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON (B)(4) 2012. (B)(4) /2012: CORRECTION: THE INITIAL MDR HAD THE BOX "[X] HOSPITALIZATION - INITIAL OR PROLONGED" CHECKED BY MISTAKE. THIS STATEMENT REGARDING HOSPITALIZATION IS INCORRECT. THE STATEMENT "IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HBC TOTAL RESULT."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2012-00408 ON (B)(4) 2012. SIEMENS FILED THE MDR 1219913-2012-00408 SUPPLEMENTAL REPORT ON (B)(4) 2012. (B)(4) /2013 ADDITIONAL INFORMATION: THE CUSTOMER SENT FOUR PATIENT SAMPLES TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING AND INVESTIGATION. THE SAMPLES WERE TESTED ON MULTIPLE LOTS FOR THE ADVIA CENTAUR HBC TOTAL ASSAY. THE LOT NUMBERS WERE 100049, 100051 AND 100053. RESULTS: SAMPLE (B)(4) WAS NEGATIVE ACROSS ALL LOTS TESTED. THE SAMPLE WAS (B)(6) WITH (B)(6). DEPENDING UPON THE (B)(6) RESULT, THIS SAMPLE WOULD BE CLASSIFIED AS RECOVERY OR VACCINATED. SAMPLE (B)(4) WAS (B)(6) FOR LOTS 100049 AND LOT 100051 AND (B)(6) ON LOT 100053. THIS SAMPLE WAS (B)(6) FOR (B)(6). SAMPLE (B)(4) WAS (B)(6) ACROSS LOTS 100049, 100051 AND LOT 100053. SIEMENS DID NOT CONFIRM THE (B)(6) RESULT OBTAINED BY THE CUSTOMER. SAMPLE (B)(4) WAS (B)(6) ACROSS LOTS 100049, 100053 AND NONREACTIVE IN LOT 100051. THIS SAMPLE IS A BORDERLINE SAMPLE IN (B)(6) TOTAL AND (B)(6) IN (B)(6). THIS IS A RECOVERED SAMPLE. THE CAUSE FOR THE (B)(6) ADVIA CENTAUR XP HBC TOTAL RESULTS IS UNKNOWN. THE IFU (07063154 REV. P) DISTRIBUTED OUTSIDE THE U.S. STATES IN THE LIMITATIONS SECTION : "THE ADVIA CENTAUR HBC TOTAL ASSAY IS LIMITED TO THE DETECTION OF TOTAL ANTIBODIES TO (B)(6) ANTIGEN IN HUMAN SERUM OR EDTA PLASMA. ASSAYS FOR THE DETECTION OF ANTI-HBC MAY NOT IDENTIFY ALL PATIENT SAMPLES THAT CONTAIN (B)(6) VIRUS OR POTENTIALLY INFECTIOUS UNITS OF BLOOD AND MAY GENERATE (B)(6) RESULTS. ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR HBC TOTAL ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAY FOR SPECIFIC HBV SEROLOGICAL MARKERS."

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP HBC TOTAL RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU (07063154 REV. P) DISTRIBUTED OUTSIDE THE U.S, STATES IN THE LIMITATIONS SECTION : "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 HBC TOTAL ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAY FOR SPECIFIC (B)(6)."

    Description of Event or Problem · 1

    (B)(6) ADVIA CENTAUR XP HBC TOTAL RESULTS WERE OBTAINED ON SAMPLES FROM SEVERAL PATIENTS WHEN USING LOT# 049 AND 050. THE PATIENT SAMPLES WERE TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE (B)(6). IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HBC TOTAL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HBC TOTAL (HBCT) ASSAY HBCT IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 049 AND 050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization