BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE

    MDR report key: 2410470 · Received January 11, 2012

    Report

    Report Number
    1415939-2012-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Report Date
    November 17, 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
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), NO CONSEQUENCES OR IMPACT TO PATIENT, FALSE NEGATIVE RESULT, FALSE POSITIVE RESULT. 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.

    Description of Event or Problem · 1

    THE CUSTOMER STATED CYCLOSPORINE QUALITY CONTROLS WERE ERRATIC ON AN ARCHITECT I1000SR ANALYZER. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CYCLOSPORINE MKW ABBOTT LABORATORIES 02079M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I1000SR LN 01L86-01 SN (B)(4)