BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 4140355 · Received October 3, 2014

    Report

    Report Number
    1415939-2014-00217
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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).

    Additional Manufacturer Narrative · 1

    THERE WERE NO RETURNS FROM THE CUSTOMER SITE AVAILABLE FOR THIS EVALUATION. ACCURACY TESTING WAS PERFORMED IN-HOUSE WITH RETAINED REAGENTS OF LOT 35233M500 (LIST 02K91-25). AN ARCHITECT CA 19-9XR PANEL CONSISTING OF FOUR DIFFERENT LEVELS OF ANALYTE CONCENTRATIONS WAS TESTED. TWO REPLICATES OF EACH PANEL LEVEL WERE TESTED 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 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. THE FALSELY ELEVATED RESULT IS FOR A SINGLE PATIENT AND RETESTS WITH THE PARENT SAMPLE AND THE SAME REAGENT LOT GAVE THE EXPECTED RESULTS, WHICH INDICATES A POTENTIAL SAMPLE INTEGRITY OR SAMPLE HANDLING ISSUE. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS AN INITIAL ARCHITECT CA 19-9XR ASSAY RESULT OF 89.9 U/ML (A SAMPLE POUR OFF FROM THE ORIGINAL COLLECTION TUBE). THE RESULT WAS REPORTED FROM THE LAB AND QUESTIONED BY THE PATIENT'S PHYSICIAN. THE ORIGINAL COLLECTION TUBE SAMPLE WAS RETESTED THE NEXT DAY AND GENERATED RESULTS OF 10.2 AND 10.4 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
    619189 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT LABORATORIES 35233M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER| ARCHITECT I1000SR ANALYZER| LN: 01L86-01 SN: (B)(4).| LN: 01L86-01 SN: (B)(4).