BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3890252 · Received June 24, 2014

    Report

    Report Number
    1415939-2014-00133
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    March 12, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN-PROCESS.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE. AN ACCURACY TESTING PROTOCOL WAS EXECUTED UTILIZING LOT 31110M500. IN ADDITION TO THE ACCURACY TESTING, AN ANALYSIS UTILIZING FIELD DATA WAS COMPLETED TO DETERMINE IF THE MEDIAN PATIENT VALUES HAVE SHIFTED OVER TIME. THE ANALYSIS CONCLUDED THAT ALL REAGENT LOTS READ PATIENT RESULTS CONSISTENTLY THEREFORE DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT CA19-9XR REAGENT, LIST NUMBER 02K91, LOT 31110M500, WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED ELEVATED CA19-9 RESULTS WHILE USING THE ARCHITECT CA19-9XR ASSAY ON THE ARCHITECT I2000SR ANALYZER. THE CUSTOMER INDICATED THAT THE RESULTS WERE NOT DISCREPANT AS THIS PATIENT IS KNOWN TO GENERATE HIGH RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS FOR ONE PATIENT: (B)(6) 2014: 75,000 IU/ML. (B)(6) 2014: >120,000 (TWICE). (B)(6) 2014: > 120,000. (B)(6) 2014: >240,000. HETEROPHILIC ANTIBODY TESTING WAS PERFORMED, NO INTERFERENCE IS SUSPECTED AS THE RESULT ALSO GENERATED A RESULT OF >240,000. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367718 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT LABORATORIES 31110M500

    Patients

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