BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP HCV ASSAY

    MDR report key: 1659082 · Received April 8, 2010

    Report

    Report Number
    1219913-2010-00041
    Event Type
    Other
    Date Received
    April 8, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 25, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS REPRESENTATIVE REVIEWED THE ACCOUNT'S HISTORY AND NO ISSUES WERE FOUND IN THE TIME FRAME OF THE DISCORDANT RESULTS. THE CAUSE FOR THE (B)(6) ADVIA CENTAUR ANTI-HCV RESULTS COMPARED TO THE (B)(6) RESULT FOR THE OTHER METHODS IS UNKNOWN. THE INSTRUCTION FOR USE (IFU) LIMITATION SECTION STATES: "A NEGATIVE TEST RESULTS 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 MANUFACTURER'S ASSAYS FOR SPECIFIC HCV SEROLOGIC MARKERS."

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR XP HCV RESULT WAS OBTAINED ON A PATIENT SAMPLE DURING A CORRELATION STUDY. THE SAMPLE WAS TESTED ON THE LABORATORY'S ALTERNATE METHOD AND THE RESULT WAS (B)(6). THE SAMPLE WAS SENT OUT FOR RIBA TESTING AND THE RESULT WAS (B)(6). THE SAMPLE WAS THEN TESTED ON BOTH SYSTEM AND THE RESULTS WERE THE SAME ((B)(6) ON THE ADVIA CENTAUR XP AND (B)(6) ON THE ALTERNATE METHOD). PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NOT REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR ANTI-HCV RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HCV ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS NA 215

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR