BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2635212 · Received June 29, 2012

    Report

    Report Number
    1415939-2012-01225
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Report Date
    May 31, 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
    EZ
    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 IS OBSERVING HIGHER THAN EXPECTED ARCHITECT CA 19-9XR ASSAY RESULTS WHEN USING REAGENT LOT 08851M500. THE CUSTOMER STATED ONE PATIENT SAMPLE GENERATED A FALSELY ELEVATED RESULT OF 23.61 U/ML USING ARCHITECT CA19-9XR LOT 08851M500. THE PATIENT GENERATED A CA 19-9 RESULT OF 8.57 U/ML USING LOT 12092M500. THE SAMPLE WAS THEN RUN ON A COBAS E601 ANALYZER AND A CA 19-9 RESULT OF 13.26 WAS GENERATED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 08851M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN 03M74-01 SN (B)(4)