BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2924519 · Received January 22, 2013

    Report

    Report Number
    1415939-2013-00019
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCURACY OF THE REAGENT LOT 18070M500 WAS PERFORMED. FOUR LEVELS OF AN INTERNAL PANEL WERE TESTED ACROSS THREE ARCHITECT I SYSTEMS. EACH LEVEL CONTAINS A KNOWN CONCENTRATION OF THE CA 19-9 ANALYTE. THE RESULTS MET TESTING SPECIFICATIONS. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-35 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-27. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A FALSELY ELEVATED ARCHITECT CA 19-9XR ASSAY RESULT FOR ONE PATIENT. AN INITIAL RESULT OF 101.3 U/ML RETESTED AT 15.54 U/ML. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31394 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 18070M500

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR ARCHITECT I2000SR LN:03M74-02 SN: (B)(4)| ARC I2000SR LN: 03M74-02 SN: (B)(4)