BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 1594552 · Received February 4, 2010

    Report

    Report Number
    1415939-2010-00235
    Event Type
    Malfunction
    Date Received
    February 4, 2010
    Date of Event
    January 12, 2010
    Report Date
    January 12, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 ONE PATIENT SAMPLE GENERATED AN ARCHITECT CA-125 RESULT OF 37, 37 AND 37 U/ML WITH LOT # 77486M100. THE SAMPLE WAS RUN ON A SECOND ANALYZER WITH RESULTS OF 103, 101 AND 102 U/ML USING LOT 75249M100. THE SAMPLE WAS REPEATED ON THE SECOND ANALYZER USING LOT 77486M100 AND THE RESULT WAS 36.0 U/ML. THE ELEVATED RESULT WAS QUESTIONED. 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 75249M100

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ANALYZER 3M74-01 (B)(4)| ARCHITECT ANALYZER 3M74-01 (B)(4)