BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3170269 · Received June 14, 2013

    Report

    Report Number
    1415939-2013-00263
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    June 3, 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

    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 02K91-35 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-27. (B)(4). DATE OF EVENT IS DOCUMENTED IN THE CUSTOMER COMPLAINT AS (B)(6) 2013. DATE OF RECEIPT OF COMPLAINT IS DATED (B)(6) 2013. BECAUSE OF INTERNATIONAL DATELINE/TIME ZONE ISSUES THIS APPEARS AS A DISCREPANCY IN DATING BUT ACTUALLY IS NOT. THEREFORE, THE EVENT DATE WAS ENTERED AS UNKNOWN TO AVOID ANY CONFUSION.

    Additional Manufacturer Narrative · 1

    INFORMATION FROM THE CUSTOMER SITE INDICATES THAT A RETEST OF THE ORIGINAL SAMPLE GENERATED THE EXPECTED RESULTS. THIS WAS A SINGLE SAMPLE ISSUE, WHICH WAS RESOLVED UPON RETESTING. ALSO, A NUMBER OF ASPIRATION ERRORS GENERATED INDICATE A PROBABLE SAMPLE ISSUE. ACCURACY TESTING WAS PERFORMED WITH IN-HOUSE RETAINED REAGENTS OF LOT 20214M500 (LIST 02K91-35). AN ARCHITECT CA 19-9XR PANEL, CONSISTING OF FOUR DIFFERENT LEVELS OF ANALYTE CONCENTRATION, 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. 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.

    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 335.40 U/ML WAS GENERATED THAT WAS SUBSEQUENTLY RETESTED AND GENERATED A RESULT OF 3.10 U/ML. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272039 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 20214M500

    Patients

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