BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 1487995 · Received September 30, 2009

    Report

    Report Number
    1415939-2009-01125
    Event Type
    Injury
    Date Received
    September 30, 2009
    Date of Event
    January 17, 2009
    Report Date
    June 15, 2009
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. ONE ARCHITECT INSTRUMENT WAS CALIBRATED AND CONTROLS WERE RUN TO VALIDATE THE CURVE. TESTING WAS DONE USING FILE KITS OF CA 125 REAGENT, LIST NUMBER 2K45, LOT 69463M100 AND CA 125 PANEL SET PN 220-095 (LEVEL 1), PN 220-100 (LEVEL 2), PN 220-105 (LEVEL 3), LOT 53NY. ONE REPLICATE OF EACH PANEL LEVEL WAS TESTED. VALIDITY CRITERIA MET. ACCEPTANCE CRITERIA MET; EACH PANEL REPLICATE WAS WITHIN SPECIFICATION RANGE. THIS TESTING SUPPORTS THE FACT THAT THIS PRODUCT IS CAPABLE OF PROVIDING ACCURATE RESULTS. COMPLAINT TRACKING AND TRENDING WERE REVIEWED AND FOUND NO PRODUCT ISSUES. ACCEPTANCE CRITERIA WERE MET. THE ARCHITECT STAT CA 125 REAGENT PACKAGE INSERT (016-622 5/07) CONTAINS ADEQUATE INFORMATION REGARDING THE CUSTOMER'S ISSUE IN REGARDS TO COMPARING DIFFERENT METHODOLOGIES. THE INVESTIGATION DID NOT IDENTIFY ANY PRODUCT DEFICIENCIES; THE PRODUCT IS PERFORMING AS INTENDED. NO ADDITIONAL ISSUES WITH THIS LIST NUMBER WERE IDENTIFIED. NO FURTHER INVESTIGATION WILL BE PERFORMED. THE ASSAY IS PERFORMING AS INTENDED, AND MEETING ITS SAFETY, EFFECTIVENESS AND LABEL CLAIMS. THIS IS A FINAL REPORT.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE FEMALE PATIENT, WHO IS A KNOWN HEPATITIS B CARRIER, PRESENTED WITH AN OVARIAN LUMP AND THAT AN ARCHITECT CA 125 TEST ORDERED FOR THIS PATIENT GENERATED A RESULT OF 618.4 U/ML. A LAPAROTOMY AND OOPHORECTOMY WERE PERFORMED AND THE OVARIES WERE FOUND TO BE ATROPHIC. IN 2009, ANOTHER SAMPLE WAS DRAWN FROM THIS PATIENT AND GENERATED AN ARCHITECT CA 125 ASSAY RESULT OF 1595 U/ML. AT APPROXIMATELY ONE MONTH LATER, ANOTHER SAMPLE WAS DRAWN FROM THIS PATIENT, AND GENERATED AN ARCHITECT CA 125 ASSAY RESULT OF 1397 U/ML. THE PATIENT THEN UNDERWENT A PET AND CT WITH NEGATIVE RESULTS. THE LATEST SAMPLE DOCUMENTED ABOVE GENERATED "NORMAL" RESULTS ON THREE OTHER PLATFORMS/METHODOLOGIES. THE SAMPLE WAS RETESTED AGAIN ON THE ARCHITECT I2000 ANALYZER AND GENERATED RESULTS OF 995.25, >1000 AND >1000 U/ML. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT 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 69463M100

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability ARCH I2000SR ANALYZER LN:3M74-02