BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR XP HCV ASSAY

    MDR report key: 2062303 · Received April 19, 2011

    Report

    Report Number
    1219913-2011-00052
    Date Received
    April 19, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 25, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP HCV RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUCTION FOR USE (IFU) LIMITATION SECTION STATES: "THE RESULTS FROM THIS OR ANY OTHER DIAGNOSTIC KIT SHOULD BE USED AND INTERPRETED ONLY IN THE CONTEXT OF THE OVERALL CLINICAL PICTURE. (B)(4)."

    Description of Event or Problem · 1

    (B)(6) ADVIA CENTAUR XP HCV RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON TWO OTHER ALTERNATE METHODS AND THE RESULTS WERE (B)(6). PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HCV RESULTS.

    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 220

    Patients

    Seq Age Sex Outcome Treatment
    1