BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3122397 · Received May 21, 2013

    Report

    Report Number
    1415939-2013-00216
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 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 02K91-25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-27. (B)(4).

    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 (LOWER) RESULTS. ACCURACY TESTING WAS PERFORMED IN-HOUSE WITH RETAINED REAGENTS OF LOT 20278M500 (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 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 (B)(6) ARCHITECT CA 19-9XR ASSAY RESULT OF (B)(6) GENERATED FOR ONE PATIENT SAMPLE. THE SAMPLE RETESTED AT LESS THAN (B)(6). THE CUSTOMER THEN TESTED AN ALIQUOT FROM THE ORIGINAL SAMPLE COLLECTION TUBE AND GENERATED A RESULT OF (B)(6). SAMPLES FROM THIS PATIENT WERE TESTED THREE MORE TIMES AND EACH RESULT GENERATED WAS (B)(6). NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. CONTROLS HAVE BEEN WITHIN SPECIFICATIONS. THERE IS NO PATIENT INFORMATION AVAILABLE FROM THE CUSTOMER SITE. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224516 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 20278M500

    Patients

    Seq Age Sex Outcome Treatment
    1 SN: (B)(4)| ARCHITECT I2000SR ANALYZER LN: 03M74-01,