BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE

    MDR report key: 2241202 · Received September 9, 2011

    Report

    Report Number
    1415939-2011-00566
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MKW
    PMA / PMN Number
    K080751
    Removal / Correction Number
    1415939-10/10/11-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE ARCHTIECT CYCLOSPORINE IMPRECISION IS DUE TO AN INTERACTION BETWEEN THE ARCHITECT CYLCOSPORINE ASSAY AND THE RESIN USED TO PRODUCE CERTAIN ARCHITECT REACTION VESSEL (RV) LOTS. ASSAY PRECISION CAN BE IMPACTED IF RVS CONTAINING DIFFERENT RESIN ARE MIXED IN THE ARCHITECT HOPPER AND USED TO TEST ARCHITECT CYCLOSPORINE. ALL ARCHITECT CYCLOSPORINE CUSTOMERS WILL BE INSTRUCTED TO ONLY RUN ARCHITECT CYCLOSPORINE USING RVS MANUFACTURED WITH RESIN FROM THE SAME SUPPLIER. RV LOTS BEGINNING WITH LOT 06083P100 AND HIGHER CAN BE USED TOGETHER. RV LOTS LOWER THAN 06083P100 CAN BE USED TOGETHER.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT UNEXPECTED ELEVATED ARCHITECT CYCLOSPORINE RESULTS WERE GENERATED FOR PATIENT SAMPLES. WHILE TROUBLESHOOTING THE ISSUE, THE CUSTOMER PULLED THREE PREVIOUSLY TESTED SAMPLES AND RERAN THEM. PATIENT SAMPLE #3 GENERATED A RESULT OF 344 NG/ML. THE SAMPLE HAD ORIGINALLY TESTED AT 99 NG/ML. THE ELEVATED RESULT WAS NOT REPORTED OUT OF THE LABORATORY AS TESTING WAS PERFORMED FOR TROUBLESHOOTING PURPOSES ONLY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CYCLOSPORINE MKW ABBOTT LABORATORIES 01107M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN 03M74-02 (B)(4)| ARCHITECT I2000SR LIST 3M74-02, (B)(4)