BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 2471138 · Received February 28, 2012

    Report

    Report Number
    1415939-2012-00052
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Report Date
    February 6, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. ACCURACY TESTING WAS PERFORMED USING LIKELY CAUSE LOT 05023M500. THREE PANELS OF KNOWN CONCENTRATION WERE TESTED ON ONE ARCHITECT INSTRUMENT AND EACH PANEL REPLICATE WAS WITHIN THE RESPECTIVE ACCEPTANCE RANGES. CUSTOMER COMPLAINTS WERE REVIEWED TO DETERMINE IF OTHERS HAVE EXPERIENCED THIS ISSUE. NO UNUSUAL ACTIVITY RELATED TO DISCREPANT RESULTS FOR LOT 05023M500 WAS IDENTIFIED. BASED ON THE EVALUATION RESULTS, NO PRODUCT DEFICIENCY WAS IDENTIFIED RELATED TO THE ALLEGED MALFUNCTION REPORTED BY THE CUSTOMER. HOWEVER, THE CUSTOMER WAS REFERRED TO THE ASSAY PACKAGE INSERT REGARDING THE INTENDED USE OF THE ASSAY (CA 125 II ASSAY VALUES SHOULD BE USED IN CONJUNCTION WITH OTHER CLINICAL METHODS USED FOR MONITORING OVARIAN CANCER) AND THE LIMITATIONS OF THE PROCEDURE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT ((B)(6) WOMAN) SAMPLE GENERATED DISCREPANT AND HIGHER THAN EXPECTED RESULTS FOR THE ARCHITECT CA125 ASSAY. A RESULT OF 3000 KU/L WAS REPEATED AT 15000 KU/L AND WAS STILL HIGH WITH DILUTION (NO RESULTS PROVIDED). A RESULT OF 3600 KU/L WAS OBTAINED WHEN THE PATIENT SAMPLE WAS TESTED USING ANOTHER (NON-ABBOTT) METHOD. SUSPECT RESULTS WERE NOT REPORTED OUT AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 125 II LTK ABBOTT LABORATORIES 05023M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000 ANALYZER (B)(4)| ARCHITECT I2000 ANALYZER (B)(4)