BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 1647903 · Received April 1, 2010

    Report

    Report Number
    1415939-2010-00290
    Event Type
    Malfunction
    Date Received
    April 1, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 22, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A PATIENT SAMPLE GENERATED A FALSELY ELEVATED CA 125 RESULT OR 85.5 U/ML COMPARED TO A REPEAT RESULT OF 40.8 U/ML OBTAINED USING A DIFFERENT LOT OF REAGENT. NO ADVERSE OUTCOMES WERE REPORTED RELATED TO THIS ISSUE.

    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 75248M100

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ANALYZER LN 8C89-01, (B)(4)| ARCHITECT ANALYZER LN 8C89-01, (B)(4)