BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II

    MDR report key: 2858659 · Received December 5, 2012

    Report

    Report Number
    1415939-2012-02089
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    October 5, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    PMA / PMN Number
    K042731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCURACY TESTING WAS REVIEWED FOR A REPRESENTATIVE LOT OF ARCHITECT CA 125 II (12341M500), SINCE THE LIKELY CAUSE LOT EXPIRED JUNE 22, 2012 AND FURTHER EVALUATION WAS NOT ABLE TO BE PERFORMED. ACCEPTANCE CRITERIA WERE MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED FOR THE LIKELY CAUSE LOT 04202M500. DURING THE REVIEW OF THE COMPLAINT TEXT IT WAS NOTED THAT THE REAGENT KIT EXPIRED JUNE 22, 2012 AND THE DISCREPANT RESULTS WERE OBTAINED FOR THE PATIENT ON (B)(6) 2012 BEYOND THE EXPIRATION OF THE KIT. THE ARCHITECT CA 125 II REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION/DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ON (B)(6) 2012, A FALSELY ELEVATED ARCHITECT CA 125 RESULT OF 698 U/ML WAS GENERATED ON A PATIENT HAVING A GENERAL PHYSICAL EXAM. THE SAMPLE WAS REPEATED AND A RESULT OF 736 U/ML WAS GENERATED. THE PATIENT RETURNED ON (B)(6) 2012, AND A NEW SAMPLE GENERATED A RESULT OF 25.0 U/ML. A PLASMA SAMPLE FROM (B)(6) 2012, WAS TESTED AND A RESULT OF 614 U/ML WAS GENERATED. 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 LTK ABBOTT LABORATORIES 04202M500

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR ARCHITECT I2000SR ANALYZER 3M74-01| SN (B)(4)| SN (B)(4)| ARCHITECT I2000SR ANALYZER 3M74-01