BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV ASSAY

    MDR report key: 3191579 · Received June 26, 2013

    Report

    Report Number
    1219913-2013-00141
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) PATIENT RESULT ON THE ADVIA CENTAUR XP SYSTEM WHEN COMPARED TO A (B)(6) RESULT ON ONE ALTERNATE TEST METHOD AND (B)(6) RESULTS ON TWO OTHER ALTERNATE (B)(6) TEST METHODS IS UNKNOWN. SIEMENS HAS REQUESTED THE DISCORDANT SAMPLE FOR FURTHER INVESTIGATION. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING IN THE LIMITATION SECTION: "A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH (B)(6). (B)(6) ANTIBODIES MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS. ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR HCV ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC (B)(6) SEROLOGICAL MARKERS."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2013-00141 0N 06/26/2013 FOR A (B)(6) PATIENT RESULT. 09/23/2013 - ADDITIONAL TEST INFORMATION: THE CUSTOMER PROVIDED A PATIENT SAMPLE FOR FURTHER INVESTIGATION BY SIEMENS. THE SAMPLE WAS TESTED ON MULTIPLE ADVIA CENTAUR (B)(6) REAGENT LOTS AND THE RESULTS WERE NEGATIVE AS INITIALLY OBSERVED BY THE CUSTOMER WITH ADVIA CENTAUR XP REAGENT LOT # 235. IN SUMMARY, BASED UPON THE ADDITIONAL TESTING PERFORMED BY SIEMENS, THIS IS NOT CONSIDERED A REAGENT LOT OR SYSTEM PERFORMANCE ISSUE AND THERE IS NO EVIDENCE CONCERNING LOSS OF SENSITIVITY BASED ON SERO-CONVERSION PANELS, GENOTYPE PANELS, AND DILUTION OF SAMPLES CLOSE TO ASSAY CUT OFF. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. SIEMENS ADVIA CENTAUR (B)(6) TEST RESULTS: (B)(6). THE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING IN THE LIMITATION SECTION: "A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH HCV. HCV ANTIBODIES MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS. ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR HCV ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC HCV SEROLOGICAL MARKERS."

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR XP HCV RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO ALTERNATE (B)(6) TEST METHOD (B)(6) RESULTS. AFTER THE INITIAL (B)(6) TEST RESULT, THE CUSTOMER PERFORMED CONFIRMATION (B)(6) TESTING ON TWO ALTERNATE (B)(6) TEST METHODS. ONE OF THE ALTERNATE TEST METHOD RESULT WAS (B)(6) AND THE OTHER ALTERNATE TEST METHOD RESULT WAS (B)(6). THE SAMPLE WAS TESTED ON A THIRD ALTERNATE (B)(6) TEST METHOD AND THE RESULT WAS (B)(6). THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XP HCV RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291590 ADVIA CENTAUR XP HCV ASSAY HEPATITIS C VIRUS (ANTI-HCV) MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 235

    Patients

    Seq Age Sex Outcome Treatment
    1