BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2823114 · Received November 7, 2012

    Report

    Report Number
    1415939-2012-02070
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 5, 2012
    Report Date
    November 2, 2012
    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

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-27. (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    INFORMATION FROM THE CUSTOMER SITE INDICATES THAT A RETEST OF THE ORIGINAL SAMPLE DID NOT REPRODUCE THE INITIALLY GENERATED (FALSELY) ELEVATED RESULT. RETESTING OF THE SAMPLE GENERATED THE EXPECTED RESULT. ACCURACY TESTING WAS PERFORMED IN-HOUSE WITH RETAINED REAGENTS OF LOT 14780M500 (LIST 02K91-25). AN ARCHITECT CA 19-9XR PANEL, CONSISTING OF FOUR DIFFERENT LEVELS OF ANALYTE CONCENTRATION, WAS TESTED. TWO REPLICATES OF EACH PANEL LEVEL WERE TESTED IN DUPLICATE ACROSS THREE SEPARATE ARCHITECT ISYSTEMS. ALL RESULTS MET SPECIFICATIONS. THIS DEMONSTRATES THAT THE ASSAY CAN ACCURATELY DETECT KNOWN CONCENTRATIONS OF THE CA 19-9 ANTIGEN. COMPLAINT ACTIVITY WAS REVIEWED AND IDENTIFIED NO ADVERSE TRENDS IN ASSOCIATION WITH THE ISSUE CURRENTLY UNDER EVALUATION. THE TREND REVIEW IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. THE TICKET REVIEW FOR THE LIKELY CAUSE LOT IDENTIFIED ATYPICAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER REVIEW. THE ARCHITECT CA 19-9XR ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. THE CURRENT EVALUATION INDICATES THAT THE ARCHITECT CA 19-9XR REAGENT KIT IS PERFORMING AS INTENDED AND NO NEW ISSUES WERE FOUND. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A FALSELY ELEVATED ARCHITECT CA 19-9XR ASSAY RESULT FOR ONE PATIENT OF 861 U/ML. PREVIOUS RESULTS FOR THIS PATIENT ((B)(6) 2012) HAVE GENERATED RESULTS AROUND 30 U/ML. CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 14780M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC I2000 LN: 08C89-01 SN: (B)(4)| ARC I2000 LN: 08C89-01 SN: (B)(4)