BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2634994 · Received June 29, 2012

    Report

    Report Number
    1415939-2012-01241
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Report Date
    March 21, 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
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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 THAT THE CURRENT ARCHITECT CA19-9XR REAGENT LOT (08851M500) IN USE DEMONSTRATED A SLOPE OF 2.28 ON PATIENT RESULTS, WHILE A NEW LOT HAD A SLOPE OF 1.26. NO SPECIFIC PATIENT DATA WAS PROVIDED. THE CUSTOMER IS REQUESTING REPLACEMENT OF ALL BOXES OF CURRENT LOT. 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 08851M500

    Patients

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