BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2620257 · Received June 18, 2012

    Report

    Report Number
    1415939-2012-00774
    Event Type
    Malfunction
    Date Received
    June 18, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 16, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Removal / Correction Number
    1415939-05/30/12-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE ISSUE REVEALED THAT THE CONJUGATE COMPONENT OF THE ARCHITECT CA19-9XR AFFECTED REAGENT LOTS CONTRIBUTED TO ELEVATED CA19-9XR PATIENT SAMPLE CONCENTRATIONS. ALL AFFECTED LOTS SHARE THE SAME CONJUGATE COMPONENT. ABBOTT ISSUED A PRODUCT RECALL FOR THE SIX AFFECTED LOTS (08851M500, 08849M500, 10122M500, 08852M500, 08853M500, 10040M500) OF THE ARCHITECT CA19-9XR REAGENT, INSTRUCTING CUSTOMERS TO DISCONTINUE USE AND DESTROY ANY REMAINING INVENTORY OF THE AFFECTED LOTS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED CA19-9 RESULTS WHEN ARCHITECT CA19-9 XR LOT 10040M500 WAS IN USE. THE CUSTOMER PROVIDED AN EXAMPLE OF ELEVATED RESULTS IN U/ML FOR SID (B)(4): 50.89 AND 45.66. REPEAT TESTING WITH REAGENT LOT 12343M500 GENERATED A RESULT OF 14.87. THE CUSTOMER STATED CONTROLS WERE ACCEPTABLE AND NO ARCHITECT ERRORS WERE PRODUCED WHEN ELEVATED RESULTS WERE GENERATED. TROUBLESHOOTING OF THE ISSUE WAS DONE BY PERFORMING CHECKS OF THE ARCHITECT, HOWEVER, THE ISSUE WAS RESOLVED WITH A DIFFERENT LOT OF REAGENT. THE FALSELY ELEVATED RESULTS WERE NOT REPORTED OUT THE LAB, THEREFORE, THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 10040M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR, LIST # 3M74-02, SN (B)(4)