BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2894925 · Received January 3, 2013

    Report

    Report Number
    1415939-2013-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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).

    Additional Manufacturer Narrative · 1

    ACCURACY TESTING WAS PERFORMED IN-HOUSE WITH RETAINED REAGENTS OF LOT 13517M500 (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. THE TICKET REVIEW FOR THE LIKELY CAUSE LOT IDENTIFIED ATYPICAL COMPLAINT ACTIVITY FOR THE ISSUE 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 CA19-9XR REAGENT KIT IS PERFORMING AS INTENDED AND NO NEW ISSUES WERE FOUND. THIS ISSUE WAS LIMITED TO A DISCREET NUMBER OF SAMPLES FROM THE SAME PATIENT. ADDITIONALLY, METHOD COMPARISON IS NOT ALLOWED PER THE PRODUCT LABELING. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS FALSELY ELEVATED ARCHITECT CA 19-9XR ASSAY RESULTS FOR ONE PATIENT. THE PATIENT HAS GENERATED RESULTS OF 5 U/ML IN (B)(6) 2012 AND 39.15 U/ML (B)(4) IN (B)(6) 2012. THE MOST RECENT SAMPLE GENERATED RESULTS OF 71.62 (B)(4) AND 74.11 (B)(4) U/ML. THE SAMPLE WAS RECENTRIFUGED AND SERUM TAKEN OFF THE CLOT AND RETESTED WITH RESULTS OF 61.06 (B)(4) AND 58.31(B)(4) U/ML. THE SAMPLE WAS SENT TO ANOTHER LAB WHERE RESULTS OF 15.2 AND 15.4 U/ML WERE GENERATED (METHODOLOGY NOT AVAILABLE). CONTROLS HAVE BEEN WITHIN SPECIFICATIONS. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB WITH NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 13517M500

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE LN: 08C94-42| PROBE LN: 08C94-42| ARCHITECT I2000SR ANALYZER LN: 03M74-02| SN: (B)(4)| ARC I2000SR LN: 03M74-02 SN: (B)(4)