BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 1639855 · Received March 25, 2010

    Report

    Report Number
    1415939-2010-00278
    Event Type
    Malfunction
    Date Received
    March 25, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 9, 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 ON (B)(6), 2010 AN ELEVATED ARCHITECT CA 125 RESULT OF 67.4 U/ML (WITH A SIMILAR REPEAT RESULT) WAS GENERATED ON A FEMALE PATIENT. THE PATIENT HAD A TOTAL HYSTERECTOMY IN THE PAST AND HAD BEEN TESTED REGULARLY WITH A CA 125 VALUE OF AROUND 8.7 U/ML. THE PATIENT WAS TESTED AGAIN ON (B)(6), 2010 AND THE RESULT WAS 8.7 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 75249M100

    Patients

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