BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV (AHCV) ASSAY

    MDR report key: 3476104 · Received November 19, 2013

    Report

    Report Number
    1219913-2013-00281
    Event Type
    Malfunction
    Date Received
    November 19, 2013
    Date of Event
    November 5, 2013
    Report Date
    November 6, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "A (B)(6) 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 (B)(6) ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC (B)(6)SEROLOGICAL MARKERS. THE ADVIA CENTAUR (B)(6) ASSAY IS LIMITED TO THE DETECTION OF IGG ANTIBODIES TO (B)(6) IN HUMAN SERUM OR PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED PLASMA)."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON NOVEMBER 19, 2013. 03/31/2014 ADDITIONAL INFORMATION: THE CUSTOMER SENT THE PATIENT SAMPLE TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING AND INVESTIGATION. THE SAMPLE WAS TESTED ON MULTIPLE LOTS (LOT # 062238, 062240, AND 062243) AND WAS NONREACTIVE ACROSS ALL THE LOTS. (B)(6). BASED ON THE ABOVE TESTING AND RESULTS, THIS IS A SAMPLE SPECIFIC ISSUE. THE CAUSE OF THE DISCORDANT RESULTS IS UNKNOWN. THIS IS WHAT THE CUSTOMER HAS OBSERVED. (B)(6). NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR XP (B)(6) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS RUN ON AN ALTERNATE METHOD AND THE RESULT WAS (B)(6). CONFIRMATORY TESTING WAS (B)(6). THE APPLICATION SPECIALIST PERFORMED MONTHLY MAINTENANCE. THE PATIENT SAMPLE WAS TESTED AGAIN AND THE RESULT WAS (B)(6). REPEAT TESTING WAS PERFORMED ON THE ADVIA CENTAUR SYSTEM AT ANOTHER LABORATORY AND THE RESULT WAS (B)(6). IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599637 ADVIA CENTAUR XP HCV (AHCV) ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 062238

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR