BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2618727 · Received June 17, 2012

    Report

    Report Number
    1415939-2012-00631
    Event Type
    Malfunction
    Date Received
    June 17, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 8, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE ISSUE REVEALED THAT THE CONJUGATE COMPONENT OF THE ARCHITECT CA19-9 AFFECTED REAGENT LOTS CONTRIBUTED TO ELEVATED CA19-9 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 CA19-9 REAGENT, INSTRUCTING CUSTOMERS TO DISCONTINUE USE AND DESTROY ANY REMAINING INVENTORY OF THE AFFECTED LOTS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED ONE PATIENT SAMPLE GENERATED A FALSELY ELEVATED RESULT OF 79.5 U/ML FOR THE ARCHITECT CA19-9XR ASSAY USING LOT 8853M500. THE SAME PATIENT SAMPLE GENERATED A RESULT OF 42.1 U/ML USING ANOTHER NON-RECALL LOT (08056M500). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 08853M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR 3M74-01 SN (B)(4)