BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2803237 · Received October 24, 2012

    Report

    Report Number
    1415939-2012-02050
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 2, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TREND REVIEW IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. THE TICKET REVIEW FOR THE LIKELY CAUSE LOTS IDENTIFIED ATYPICAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER REVIEW. ACCURACY TESTING WAS COMPLETED ON LIKELY CAUSE LOT 13516M500; TESTING MEETS ACCEPTANCE CRITERIA. A LABELING REVIEW WAS ALSO PEFORMED. THE INVESTIGATION RESULTS SHOW THAT THERE IS NO PRODUCT DEFICIENCY, HOWEVER A MALFUNCTION WAS IDENTIFIED. THIS INVESTIGATION INDICATES THAT THE ARCHITECT CA19-9XR REAGENT KITS ARE PERFORMING AS INTENDED AND NO NEW ISSUES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROGRESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED INCONSISTANT ARCHITECT CA19-9XR RESULTS ON ONE PATIENT (PATIENT 3, SID (B)(6)). NO INFORMATION WAS PROVIDED REGARDING THE EXPECTED/CORRECT CA19-9 RESULT FOR PATIENT 3. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.DATA PROVIDED:PATIENT 3 ((B)(6))ARCHITECT CA19-9XR RESULTS:24SEP2012 = 21.73 U/ML;24SEP2012 = 38.92 U/ML;25SEP2012 = 15.70 U/ML;25SEP2012 = 18.45 U/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 13516M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR: LIST 03M74-97| SERIAL (B)(4).