BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2632037 · Received June 28, 2012

    Report

    Report Number
    1415939-2012-01183
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Report Date
    June 7, 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

    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 ELEVATED ARCHITECT CA19-9XR RESULTS WHICH WERE NOT CONSISTENT WITH THE PATIENT'S HISTORY WHEN REAGENT LOT 08852M500 WAS IN USE. THE CUSTOMER HAD BEEN USING REAGENT LOT 08852M500 SINCE THE END OF (B)(4). THE CUSTOMER STATED THE ISSUE WAS RESOLVED WHEN THE LOT OF REAGENT WAS REPLACED. THE CUSTOMER PROVIDED AN EXAMPLE OF FALSELY ELEVATED RESULTS IN COMPARISON TO ANOTHER REAGENT LOT, AS FOLLOWS: SAMPLE #2: REAGENT LOT 08852M500 = 135.8, DIFFERENT LOT = 76.8. THE FALSELY ELEVATED RESULTS WERE NOT REPORTED TO THE MEDICAL PROVIDER, 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 08852M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR, LIST # 1L86-01, SN (B)(4)