BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 1102040 · Received August 7, 2008

    Report

    Report Number
    1415939-2008-00497
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 125 II CMIA FOR QUANTITATION OF OC 125 DEFINED ANTIGEN LTK ABBOTT LABORATORIES NA 55867M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI