BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR HCV (AHCV) ASSAY

    MDR report key: 3637838 · Received February 20, 2014

    Report

    Report Number
    1219913-2014-00044
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 28, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00044 ON JANUARY 28, 2014 FOR (B)(6) ADVIA CENTAUR XP (B)(6) RESULTS ON A SAMPLE. THE SAMPLE WAS (B)(6) ON A DIFFERENT PLATFORM BUT (B)(6) BY WESTERN BLOT TESTING. THE SAMPLE WAS (B)(6) RNA TESTING. JUNE 2, 2014 - ADDITIONAL INFORMATION: SIEMENS RECEIVED THE SAMPLE AND TESTED IT WITH FOUR LOTS OF ADVIA CENTAUR XP (B)(4) REAGENTS, INCLUDING LOT 062242 WHICH WAS THE LOT USED BY THE CUSTOMER. LOT: 062242, RESULT (INDEX): 0.53, INTERPRETATION: (B)(4); 062243, 0.75, (B)(4); 062246, 0.53, (B)(4). THESE RESULTS CONFIRM THE CUSTOMER'S RESULT OF 0.54 INDEX WITH LOT 062242. THE DISCORDANT (B)(4) RESULT IS NOT A SITE ISSUE OR A REAGENT LOT ISSUE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE PATIENT. THE SYSTEM IS PERFORMING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) RESULT IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS HAS REQUESTED THE PATIENT SAMPLE FOR FURTHER TESTING. THE QUALITY CONTROL RESULTS ARE WITHIN THE MANUFACTURER'S RANGES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: "A (B)(4) TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH (B)(4). (B)(4) 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 (B)(4) ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC (B)(4) SEROLOGICAL MARKERS."

    Description of Event or Problem · 1

    CUSTOMER OBSERVED (B)(6) ADVIA CENTAUR XP (B)(6) RESULTS ON A SAMPLE. THE SAMPLE WAS (B)(6) ON A DIFFERENT PLATFORM BUT (B)(6) BY WESTERN BLOT TESTING. THE SAMPLE WAS (B)(6) FOR (B)(6) RNA TESTING. 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 (B)(4) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108394 ADVIA CENTAUR HCV (AHCV) ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 062242

    Patients

    Seq Age Sex Outcome Treatment
    1