BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV (AHCV) ASSAY

    MDR report key: 3667348 · Received March 7, 2014

    Report

    Report Number
    1219913-2014-00056
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    January 30, 2014
    Report Date
    February 10, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00056 ON MARCH 7, 2014 FOR A NEGATIVE RESULT USING THE ADVIA CENTAUR XP HCV (AHCV) ASSAY AND PCR. THE PATIENT WAS (B)(6) BY OTHER METHODS. ON APRIL 10, 2014 - ADDITIONAL INFORMATION: SIEMENS RECEIVED THE SAMPLE AND TESTED IT WITH ADVIA CENTAUR SYSTEMS HCV REAGENT LOTS 062239, 062240 AND 062245. THE RESULTS WERE (B)(6) WITH THE THREE REAGENT LOTS (0.57, 0.44 AND 0.44 INDEX RESPECTIVELY.) THIS INDICATES THAT THE ISSUE IS NOT A SITE SPECIFIC ISSUE OR A LOT SPECIFIC ISSUE. SIEMENS ALSO TESTED THE SAMPLE BY WESTERN BLOT AND FOUND IT TO BE INDETERMINATE WITH A 1+ BAND. SIEMENS SUGGESTS THAT THE CUSTOMER MAY CHOOSE TO TRACK THE NUMBER OF (B)(6) SAMPLES AND COMPARE THE NUMBERS TO THE CLINICAL TRIAL RESULTS IN THE INSTRUCTIONS FOR USE (IFU). SIEMENS REVIEWED THE NUMBER OF (B)(6) SAMPLES REPORTED TO SIEMENS AND CALCULATED A SENSITIVITY RATE OF 99.99% BASED ON THE NUMBER OF TESTS SHIPPED. THE CALCULATED STATISTICS SUPPORTS THE ASSAY MEETING THE INSTRUCTIONS FOR USE SENSITIVITY CLAIMS. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT HCV RESULT IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS HAS RECEIVED THE PATIENT SAMPLE FOR FURTHER TESTING.THERE ARE NO OTHER REPORTS FROM THIS SITE REGARDING DISCORDANT ADVIA CENTAUR XP HCV RESULTS.NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: "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

    THE CUSTOMER OBSERVED A (B)(6) RESULT USING THE ADVIA CENTAUR XP HCV (AHCV) ASSAY AND PCR. THE PATIENT WAS (B)(6) BY OTHER METHODS.THERE ARE NO REPORTS THAT TREATMENT WAS PRESCRIBED OR ALTERED BASED ON THE (B)(6) RESULT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES BASED ON THE (B)(6) ADVIA CENTAUR HCV RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139950 ADVIA CENTAUR XP HCV (AHCV) ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 062240

    Patients

    Seq Age Sex Outcome Treatment
    1