BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HBC TOTAL (HBCT)

    MDR report key: 3880262 · Received June 18, 2014

    Report

    Report Number
    1219913-2014-00151
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 4, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00151 ON JUNE 18, 2014. 06/24/2014 ADDITIONAL INFORMATION: THE CUSTOMER PROVIDED PREVIOUS (B)(6) TOTAL RESULTS FOR PATIENT 2 ((B)(6)). (B)(6). PATIENT 2 (SID (B)(6)) IS A TISSUE DONATOR.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00151 ON JUNE 18, 2014. SIEMENS FILED THE MDR 1219913-2014-00151 SUPPLEMENTAL REPORT 1 ON JUNE 27, 2014. ON 07/09/2014 ADDITIONAL INFORMATION: THE CUSTOMER SENT TWO SAMPLES TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING AND INVESTIGATION. ONE VIAL WAS LABELED (B)(6) AND THE SECOND VIAL WAS LABELED (B)(6). MULTI LOT TESTING WAS PERFORMED USING (B)(6) TOTAL LOT #S 100062, 100064, AND 100066 ON BOTH SAMPLES. PATIENT SAMPLE SID (B)(6) ACROSS ALL LOTS. PATIENT SAMPLE SID (B)(6) ON LOT #S 100062 AND 100066 AND REACTIVE WITH LOT 100064. PATIENT SAMPLE SID (B)(6) TOTAL (INDEX VALUE): LOT # 100062, RESULT: 0.36. 100064, 0.48. 100066, 0.35. PATIENT SAMPLE SID (B)(6) TOTAL (INDEX VALUE): LOT # 100062, RESULT: 0.45. 100064, 0.58. 100066, 0.38. THE SAMPLES WERE TESTED WITH (B)(6) LOT # 057155. THE RESULTS WERE (B)(6) FOR BOTH SAMPLES. (B)(6) RESULTS (INDEX): PATIENT SAMPLE SID (B)(6): 0.01. PATIENT SAMPLE SID (B)(6): 0.01. THE SAMPLES WERE TESTED WITH (B)(6) LOT # 106024. PATIENT SAMPLE SID (B)(6). (B)(6) RESULTS (INDEX): PATIENT SAMPLE SID (B)(6): 0.28. PATIENT SAMPLE SID (B)(6): 9.54. THE SAMPLES WERE TESTED WITH (B)(6) LOT # 060225. THE RESULTS WERE (B)(6) FOR BOTH SAMPLES. (B)(6) RESULTS (MIU/ML): PATIENT SAMPLE SID (B)(6): 293. PATIENT SAMPLE SID (B)(6): 694.37. BASED ON THE ABOVE TESTING FOR PATIENT SAMPLE SID (B)(6), THE RESULTS INDICATE THE (B)(6) PANEL MODEL OF A VACCINE RESPONSE. BASED ON THE ABOVE TESTING FOR PATIENT SAMPLE SID (B)(6), THE RESULTS INDICATE THE (B)(6) PANEL MODEL OF A RECOVERY SAMPLE.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) RESULTS IS UNKNOWN. THE PATIENTS' SAMPLES PROFILE INDICATES THAT THIS APPEARS TO BE EITHER A RECOVERED PATIENT OR VACCINATED PATIENT. THE PATIENTS' CLINICAL HISTORY IS UNAVAILABLE. 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 (B)(6) 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. 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) EX-US: THE IFU 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)(4) MAY NOT IDENTIFY ALL PATIENT SAMPLES THAT CONTAIN (B)(6) 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 (B)(6) SEROLOGICAL MARKERS."

    Description of Event or Problem · 1

    FALSE (B)(6) ADVIA CENTAUR HBC TOTAL RESULTS WERE OBTAINED FOR SAMPLES FROM TWO DIFFERENT PATIENTS. THE PATIENTS' SAMPLES WERE TESTED ON ALTERNATE METHODS AT ANOTHER LABORATORY AND THE RESULTS WERE POSITIVE. BOTH SAMPLES WERE TESTED FOR (B)(6). THE (B)(6) RESULTS WERE NEGATIVE AND THE (B)(6) 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 (B)(6) TOTAL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357820 ADVIA CENTAUR XP HBC TOTAL (HBCT) TOTAL ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC TOTAL ASSAY) LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 062

    Patients

    Seq Age Sex Outcome Treatment
    1