BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 1572681 · Received January 8, 2010

    Report

    Report Number
    1415939-2010-00056
    Event Type
    Malfunction
    Date Received
    January 8, 2010
    Date of Event
    December 3, 2009
    Report Date
    December 14, 2009
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 ACCOUNT STATED THAT A PATIENT SAMPLE GENERATED A HIGHER THAN EXPECTED ARCHITECT CA125 RESULT OF 152.2 U/ML. THE RESULT WAS REPORTED AND QUESTIONED. A NEW SAMPLE WAS OBTAINED AND RUN ON ANOTHER ARCHITECT ANALYZER WITH SIMILAR RESULTS OF 159.0 U/ML AND 161.0 U/ML. THE SAME SAMPLE WAS RUN ON OTHER SYSTEMS WITH THE FOLLOWING RESULTS: BAYER ADVIA - 11.2 U/ML, BECKMAN COULTER DXL800 - 14.3 U/ML, BECKMAN COULTER ACCESS 2 - 12.5 U/ML AND ROCHE E170 - 19.44 U/ML. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    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 71545M100

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR ARCHITECT I2000 ANALYZER 3M74-02 (B)(4)| ARCHITECT I2000 ANALYZER 3M74-02 (B)(4)