BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CA 125 II ASSAY

    MDR report key: 1839884 · Received September 16, 2010

    Report

    Report Number
    1219913-2010-00111
    Event Type
    Other
    Date Received
    September 16, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 17, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LTK
    PMA / PMN Number
    K020828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT CA 125 II RESULTS IS UNKNOWN. THE CALIBRATIONS AND DAILY QC WERE WITHIN RANGE FOR ALL THE RUNS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR CA 125 II RESULTS WERE OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON THREE DIFFERENT LOTS. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 125 II RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CA 125 II ASSAY CA 125 II IMMUNOASSAY LTK SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 140

    Patients

    Seq Age Sex Outcome Treatment
    1