BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 1183185 · Received October 3, 2008

    Report

    Report Number
    1415939-2008-00505
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    July 1, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL IDENTIFIER(S): =IN130/IL-319. ARCH CA125II ASSAY LN:2K45-20 LOT:55869M100 EXPIRES:08/07/2008. ARCH CA125II ASSAY LN: 2K45-20 LOT: 58450M200 EXPIRES:10/28/2008. ARCHITECT I2000SR ANALYZER LN: 8C89-01. 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). ARCH CA125II ASSAY: LN:2K45-20, LOT: 55869M100, EXPIRES: 07 AUG 2008, MANUFACTURE DATE: 09/01/2007. ARCH CA125II ASSAY: LN: 2K45-20, LOT: 58450M200, EXPIRES:28 OCT 2008. MANUFACTURE DATE: 01/01/2008. ARCHITECT I2000SR ANALYZER: LN: 8C89-01 SERIAL: (B)(4). THE CUSTOMER OBSERVED DISCREPANT PATIENT RESULTS WHEN USING THE ARCHITECT CA-125 II ASSAY, LIST NUMBER (LN) 2K45, LOTS 65229M200, 55869M100 AND 58450M200. THE CUSTOMER REPORTED THAT RESULTS FROM A FEMALE PATIENT DIFFERED BETWEEN THE ARCHITECT CA-125 II ASSAY AND THE AXSYM CA-125 ASSAY. THE AXSYM ASSAY YIELDED RESULTS BELOW THE CUSTOMER'S CUT-OFF OF 37 U/ML AND MOST OF THE ARCHITECT ASSAY RESULTS WERE ABOVE THE CUSTOMER'S CUT-OFF VALUE. NO RETURN MATERIAL IS REQUIRED FOR THIS INVESTIGATION; IN-HOUSE DATA WAS USED FOR THIS INVESTIGATION. THIS IS ACCEPTABLE BECAUSE THE DATA WILL PROVIDE RELIABLE INFORMATION TO ASSESS WHETHER A PRODUCT DEFICIENCY EXISTS AND WHETHER THE ASSAY IS PERFORMING AS EXPECTED. A REVIEW OF COMPLAINTS (THE SEARCH DATE PERIOD WAS EXPANDED SO IT WOULD INCLUDE THE TIME FRAME OF THE CUSTOMER'S OLDEST LOT NUMBER; THE OLDEST LOT IDENTIFIED BY THE CUSTOMER WAS MANUFACTURED IN JULY 2007) FOR THIS ISSUE WAS CONDUCTED AND FOUND THAT A HIGHER THAN NORMAL LEVEL OF COMPLAINT ACTIVITY WAS IDENTIFIED IN THE (B)(6) 2008 TIMEFRAMES; HOWEVER, AT THIS TIME, THE REVIEW OF COMPLAINT DATA INDICATES NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. THE ACCEPTANCE CRITERIA WERE MET. THE CUSTOMER'S ISSUE IS ADDRESSED IN BOTH THE ARCHITECT AND THE AXSYM PACKAGE INSERT: (B)(4) ASSAY VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. THE RESULTS REPORTED BY THE LABORATORY MUST INCLUDE THE IDENTITY OF THE (B)(4) ASSAY USED. IF, IN THE COURSE, OF MONITORING A PATIENT, THE ASSAY METHOD USED FOR DETERMINING SERIAL (B)(4) LEVELS IS CHANGED, ADDITIONAL SEQUENTIAL TESTING SHOULD BE CARRIED OUT. PRIOR TO CHANGING ASSAYS, THE LABORATORY MUST CONFIRM BASELINE VALUES FOR PATIENTS BEING SERIALLY MONITORED. THE ARCHITECT ASSAY USES A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) TECHNOLOGY WHILE THE AXSYM ASSAY USES MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TECHNOLOGY. THE ARCHITECT AND AXSYM PACKAGE INSERT LIMITATIONS OF PROCEDURE SECTIONS STATE THAT SPECIMENS FROM PATIENTS THAT HAVE RECEIVED PREPARATIONS OF MOUSE MONOCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-MOUSE ANTIBODIES (HAMA). SUCH SPECIMENS MAY SHOW EITHER FALSELY ELEVATED OR DEPRESSED VALUES WHEN TESTED WITH ASSAY KITS WHICH EMPLOY MOUSE MONOCLONAL ANTIBODIES. BOTH THE ARCHITECT CA 125 II ASSAY AND THE AXSYM CA 125 ASSAY EMPLOY MOUSE MONOCLONAL ANTIBODIES. THE ARCHITECT PACKAGE INSERT ALSO INDICATES THAT THE RESULTS FROM THIS TEST SHOULD BE USED IN CONJUNCTION WITH OTHER DATA; E.G. SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, ETC. THE INVESTIGATION CONCLUDES THAT THE ARCHITECT CA-125 II ASSAY, LN 2K45, LOTS 65229M200, 55869M100 AND 58450M200 ARE PERFORMING AS INTENDED, AND MEETING SAFETY, EFFECTIVENESS AND LABEL CLAIMS. THE INVESTIGATION DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES OR ADDITIONAL ISSUES. NO FURTHER INVESTIGATION WILL BE PERFORMED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE FEMALE PATIENT GENERATED AXSYM CA 125 ASSAY RESULTS BETWEEN 12.6 TO 30.6 U/ML BETWEEN THE YEARS OF 1999 TO 2006. THE CUSTOMER THEN SWITCHED EXCLUSIVELY TO THE ARCHITECT PLATFORM FOR TESTING BETWEEN THE YEARS 2006 TO 2008. DURING THIS YEAR (2008), THIS SAME PATIENT HAS GENERATED ARCHITECT CA 125 II ASSAY RESULT RANGING FROM 28.1 TO 130.2 U/ML. THIS PATIENT HAS BEEN SUFFERING FROM LOWER ABDOMINAL PAIN, DIZZINESS, NAUSEA AND A 15 KILOGRAM (33 POUNDS) WEIGHT LOSS IN TWO MONTHS. A DIAGNOSTIC LAPAROSCOPY WAS PERFORMED IN 2008 WITH EXCISION OF HER OVARIES, AND THE SUBSEQUENT BIOPSY WAS NEGATIVE FOR ANY MALIGNANCY. AT THE HOSPITAL WHERE THE LAPAROSCOPY WAS PERFORMED, A BLOOD SAMPLE FROM THIS PATIENT WAS TESTED ON THE AXSYM ANALYZER AND GENERATED A RESULT OF LESS THAN 37 U/ML. THE CUSTOMER'S LAB HAS CONSISTENTLY GENERATED RESULTS OF GREATER THAN 37 U/ML. A RECENT BLOOD SAMPLE FROM THIS PATIENT WAS OBTAINED AND TESTED ON BOTH PLATFORMS - AXSYM RESULTS: 8.5, 7.0, 7.6, AND 9.08 (1:2 DILUTION); ARCHITECT RESULTS: 69.3, 67.9, 67.7, AND 55.9 (AUTO-DILUTION). THE CUSTOMER NOTES THAT THIS PATIENT TAKES A LOT OF ALTERNATIVE MEDICATIONS. ALL INTERNAL AND EXTERNAL CONTROLS TESTED ON THE ARCHITECT PLATFORM HAVE ALWAYS BEEN WITHIN SPECIFICATIONS AND NO OTHER PATIENTS HAVE EXHIBITED THIS ISSUE. IT IS UNCLEAR IF THE DIAGNOSTIC LAPAROSCOPY WAS PERFORMED BASED ON THE LAB RESULTS OR UNDERLYING CLINICAL SYMPTOMS. AN INVESTIGATION IS PENDING.

    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 NA 65229M200

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR