BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV ASSAY

    MDR report key: 2879694 · Received December 19, 2012

    Report

    Report Number
    1219913-2012-00411
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) RESULTS WHEN COMPARED TO THE ALTERNATE METHOD IS UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU (113843 REV. R) THAT IS DISTRIBUTED OUTSIDE THE US STATES IN THE LIMITATIONS 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)."

    Description of Event or Problem · 1

    NEGATIVE ADVIA CENTAUR XP HCV RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULTS WERE (B)(6). SIMILAR RESULTS WERE OBTAINED FOR A SECOND PATIENT. 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 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 HEALTHCARE DIAGNOSTICS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1