BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HBC TOTAL (HBCT)

    MDR report key: 3921598 · Received July 9, 2014

    Report

    Report Number
    1219913-2014-00169
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    November 3, 2009
    Report Date
    June 16, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P040004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00169 ON JULY 09, 2014. 07/10/2014 CORRECTION: THE INITIAL REPORT, INDICATED THE EXPIRATION DATE IS 07/14/2014. THE CORRECT EXPIRATION DATE FOR LOT # 030 IS 07/14/2010. 07/14/2014 ADDITIONAL INFORMATION: THE PATIENT SAMPLE HAD INITIALLY A TRANSAMINASE RESULT AROUND 1000 IU AND BILIRUBIN STARTING AT 4. IN THE MEANWHILE, THE BILIRUBIN RESULT IS AROUND 36 AND REMAINS. ADDITIONALLY, HEPATORENAL SYNDROME WAS DETECTED. WHEN THE PATIENT WAS RECEIVED, A VIRAL LOAD OF 1 BILLION COPIES (300 BILLION IU/ML) WAS MEASURED. THE GENOTYPE IS PROBABLY D, WITH TWO ESCAPE MUTATIONS AT THE S GEN. THE PATIENT WAS REACTIVATED UNDER IMMUNOGLOBULIN SUBSTITUTION. (B)(6) CAN BE MEASURED VERY LOW. CURRENTLY THE PATIENT RECEIVES BARACLUDE. THE 2014 TESTING OF THE PATIENT SAMPLE WAS PERFORMED WITH LOT # 063 (EXPIRATION DATE 01/08/2015).

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) HBC TOTAL RESULTS IS UNKNOWN. THE PATIENT SAMPLE IS NOT AVAILABLE FOR FURTHER TESTING AND INVESTIGATION. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. US: THE IFU STATES IN THE LIMITATIONS SECTION: "THE RESULTS FROM THIS OR ANY OTHER DIAGNOSTIC KIT SHOULD BE USED AND INTERPRETED ONLY IN THE CONTEXT OF THE OVERALL CLINICAL PICTURE. A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO HEPATITIS B VIRUS. LEVELS OF ANTI-HBC MAY BE UNDETECTABLE BOTH IN EARLY INFECTION AND LATE AFTER INFECTION." "THE CALCULATED VALUES FOR HEPATITIS B IN A GIVEN SPECIMEN, AS DETERMINED BY ASSAYS FROM DIFFERENT MANUFACTURERS, CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. THE RESULTS REPORTED BY THE LABORATORY TO THE PHYSICIAN MUST INCLUDE THE IDENTITY OF THE ASSAY USED. VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY. THE REPORTED ANTIBODY LEVEL CANNOT BE CORRELATED TO AN ENDPOINT TITER." EX-US: THE IFU STATES IN THE LIMITATIONS SECTION: "THE ADVIA CENTAUR HBC TOTAL ASSAY IS LIMITED TO THE DETECTION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN IN HUMAN SERUM OR EDTA PLASMA. ASSAYS FOR THE DETECTION OF ANTI-HBC MAY NOT IDENTIFY ALL PATIENT SAMPLES THAT CONTAIN HEPATITIS B VIRUS 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 HBV SEROLOGICAL MARKERS."

    Description of Event or Problem · 1

    A FALSE (B)(6) ADVIA CENTAUR XP HBC TOTAL RESULT WAS OBTAINED FOR A PATIENT SAMPLE IN 2009. THE RESULT WAS CONSIDERED (B)(6) WHEN THE SAMPLE WAS RETESTED IN 2014 AND THE RESULT OBTAINED WAS (B)(6). THE PATIENT SAMPLE WAS ALSO TESTED WITH AN ALTERNATE METHOD AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS FROZEN SERUM FROM 2009. THE (B)(6) RESULT WAS NOT QUESTIONED IN 2009. THE PATIENT SAMPLE WAS RETESTED IN 2014 DUE TO THE OBSERVED (B)(6). IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) HBC TOTAL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400057 ADVIA CENTAUR XP HBC TOTAL (HBCT) HBCT IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 030

    Patients

    Seq Age Sex Outcome Treatment
    1