BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3132926 · Received May 29, 2013

    Report

    Report Number
    1415939-2013-00224
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED FOR THE ISSUE UNDER INVESTIGATION. ACCURACY TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE OF LOT 17160M500. THE TESTING MET THE ACCEPTANCE CRITERIA. THE ARCHITECT CA 19-9XR REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION/DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT CA19-9XR RESULT OF 311.8 U/ML WAS GENERATED ON A SAMPLE FROM (B)(6) 2013. THE PATIENT HAD BEEN PREVIOUSLY TESTED WITH LOWER RESULTS. (B)(6) 2013 SAMPLE: 8.3 U/ML, (B)(6) 2013 SAMPLE: 6.7 U/ML, (B)(6) 2013 SAMPLE: 311.8 U/ML AND A DILUTED RESULT OF 240.11 U/ML, (B)(6) 2013 SAMPLE: 9.0 U/ML. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234719 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 17160M500

    Patients

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