BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 1328589 · Received March 3, 2009

    Report

    Report Number
    1415939-2009-00053
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    January 19, 2009
    Report Date
    February 9, 2009
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE COMPLAINT DATA WAS PERFORMED TO ASSESS THE PERFORMANCE OF THE ASSAY. THE RESULTS OF THE COMPLAINT DATA REVIEW PROVIDED EVIDENCE THAT THE PRODUCT IS PERFORMING AS INTENDED. OUR INVESTIGATION HAS DETERMINED THAT THIS ASSAY IS PERFORMING ACCEPTABLY. USING A KIT OF THE SAME REAGENT LOT, 66058M100 STORED AT OUR FACILITY, WE TESTED THE ABBOTT CONTROLS AND THREE LEVELS OF ARCHITECT CA 125 PANELS WITH KNOWN CONCENTRATIONS. ALL OF THE ABBOTT CONTROLS AND PANELS MET THE SPECIFICATIONS. THIS DEMONSTRATES THAT THE ASSAY IS CAPABLE OF DETECTING KNOWN AMOUNTS OF CA 125. IN ADDITION TO TESTING, WE REVIEWED CUSTOMER COMPLAINTS RECEIVED TO-DATE TO DETERMINE IF OTHERS HAVE EXPERIENCED THE SAME ISSUE. OUR REVIEW OF THIS DATA DID NOT IDENTIFY A TREND IN REPORTS RELATED TO THE CUSTOMER'S ISSUE. THE CUSTOMER WAS REFERRED TO THE ARCHITECT CA 125 II PACKAGE INSERT (VERSION 016-622 5/07). THIS INFORMATION PROVIDES GUIDELINES ON HOW TO UTILIZE THIS ASSAY WHEN MONITORING OVARIAN CANCER PATIENTS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A PATIENT WHO HAD UNDERGONE SURGERY FOR OVARIAN CANCER GENERATED THE FOLLOWING RESULTS ON THE ARCHITECT CA 125 II ASSAY: IN 2008 CA 125 = 42 U/ML, APPROX A MONTH LATER = 265 U/ML AND IN EARLY 2009 = 277.7 U/ML. THE PATIENT TESTED NEGATIVE IN OTHER LABORATORIES (METHOD NOT STATED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 125 II FOR THE DETERMINATION OF OC 125 DEFINED ANTIGEN IN HUMAN SERUM OR PLASMA LTK ABBOTT LABORATORIES 66058M100

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR LIST # 3M74-01 (B)(4)| ARCHITECT I2000SR LIST # 3M74-01 (B)(4)