BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 3070131 · Received April 22, 2013

    Report

    Report Number
    1415939-2013-00177
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    January 21, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING, AND ACCURACY TESTING. A REVIEW OF CUSTOMER COMPLAINTS RECEIVED TO-DATE INDICATED NORMAL COMPLAINT ACTIVITY FOR THE CUSTOMER'S REPORTED ISSUE. ACCURACY TESTING WAS PERFORMED ON A RETAINED KIT OF ARCHITECT CA 125 II REAGENT LOT NUMBER 21118M500. THREE LEVELS OF AN INTERNAL PANEL MADE FROM DEFIBRINATED HUMAN PLASMA WERE TESTED AND MET ACCEPTANCE CRITERIA. THE ARCHITECT CA 125 II PACKAGE INSERT WAS REVIEWED AND SUGGESTS THAT IF THE ARCHITECT CA 125 II RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS AND PATIENTS ROUTINELY EXPOSED TO ANIMALS OR TO ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE. PATIENTS WHO HAVE RECEIVED PREPARATIONS OF MOUSE MONOCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-MOUSE ANTIBODIES (HAMA) WHICH MAY SHOW DISCREPANT RESULTS WHEN TESTED WITH KITS WHICH EMPLOY MOUSE MONOCLONAL ANTIBODIES. PATIENTS WITH CONFIRMED OVARIAN CARCINOMA MAY HAVE CA 125 ASSAY VALUES IN THE SAME RANGE AS HEALTHY INDIVIDUALS. ELEVATIONS IN CIRCULATING OC 125 DEFINED ANTIGEN MAY BE OBSERVED IN PATIENTS WITH NONMALIGNANT DISEASE. FOR THESE REASONS, A CA 125 ASSAY VALUE, REGARDLESS OF LEVEL, SHOULD NOT BE INTERPRETED AS ABSOLUTE EVIDENCE FOR THE PRESENCE OR ABSENCE OF MALIGNANT DISEASE. THE ARCHITECT CA 125 II ASSAY SHOULD NOT BE USED AS A CANCER SCREENING TEST. FROM THE WARNING SECTION OF THE PACKAGE INSERT: CA 125 ASSAY VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THIS ISSUE. A MALFUNCTION WAS NOT IDENTIFIED FOR THE ISSUE THE CUSTOMER REPORTED. THE ISSUE IS LIMITED TO A SINGLE PATIENT, AND METHOD COMPARISON IS NOT ALLOWED PER THE LABELING. BASED ON THE RESULTS OF THIS INVESTIGATION, THE ARCHITECT CA125 II REAGENTS ARE PERFORMING AS INTENDED AND NO ADDITIONAL PRODUCT ISSUES WERE IDENTIFIED. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE EVALUATION IS COMPLETE. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER IS GENERATING FALSELY ELEVATED CA 125 RESULTS ON ONE PATIENT. RESULTS PROVIDED: 45.9 U/ML (TESTING PERFORMED ON (B)(6) 2012), 71.6 U/ML (TESTING PERFORMED ON (B)(6) 2013), AND 24.5 FROM ANOTHER LAB THAT ALSO RUNS (B)(4) METHOD. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170966 ARCHITECT CA 125 II LTK ABBOTT LABORATORIES 21118M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER, LIST # 03M74-01| SERIAL # (B)(4)