BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM CA-125

    MDR report key: 1637861 · Received March 23, 2010

    Report

    Report Number
    1415939-2010-00273
    Event Type
    Malfunction
    Date Received
    March 23, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 2, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K963926
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS BEING FILED ON AN INTERNATIONAL PRODUCT (AXSYM CA-125, LN 7K55-20) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US (3B41). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE AXSYM ANALYZER GENERATED HIGHER THAN EXPECTED RESULTS FOR BOTH CA19-9 AND CA-125 ASSAYS. RESULTS OF BOTH ASSAYS WERE REPEATED WITHIN THE NORMAL RANGES. ONE PATIENT SAMPLE GENERATED AN INITIAL RESULT OF 350.40 U/ML FOR CA-125 ASSAY. A NEW SAMPLE FROM THE SAME PATIENT GENERATED A RESULT OF 13.52 U/ML ON THE SAME ANALYZER AND A RESULT OF 10.76 U/ML FOR THE SAME ASSAY WHEN TESTED ON ANOTHER AXSYM ANALYZER. SUSPECT RESULTS WERE NOT REPORTED OUT OF THE LAB AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM CA-125 FOR THE QUANTITATIVE MEASUREMENT OF CA-125 IN HUMAN SERUM LTK ABBOTT LABORATORIES 84017LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER| AXSYM ANALYZER