BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE

    MDR report key: 2923016 · Received January 18, 2013

    Report

    Report Number
    1415939-2013-00014
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MKW
    PMA / PMN Number
    K080751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEFICIENCY HAS BEEN IDENTIFIED AND AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    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

    THE PATIENT DOCUMENTED IN THIS MDR WAS FILED IN DUPLICATE UNDER MANUFACTURER'S REPORT NUMBER 1415939-2013-00022, WITH CONCOMITANT PRODUCT. ARCHITECT I2000SR ANALYZER LIST NUMBER 03M74-01), SERIAL NUMBER I(B)(4). AT THE TIME OF THE INITIAL FILING, THE CUSTOMER WAS UNSURE AS TO WHICH ANALYZER GENERATED THE DISCREPANT RESULTS. THIS CORRECTED REPORT IS BEING FILED TO INCLUDED THE SECOND ANALYZER ABOVE.

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS WERE CONDUCTED TO FIND THE PROBABLE CAUSE OF THE ARCHITECT CYCLOSPORINE ASSAY DISCREPANT PATIENT RESULTS. IT WAS CONCLUDED THAT THE MOST PROBABLE CAUSE WAS A REACTION VESSEL (RV) RESIN CHANGE SOURCED FROM A NEW VENDOR. WHEN THE CUSTOMER MIXED REACTION VESSELS FROM BOTH RESIN LOTS FOR ASSAY CALIBRATION AND/OR ASSAY TEST RUNS, AN INCREASE IN DISCREPANT RESULTS WAS SEEN ALONG WITH CALIBRATION FAILURES AND CONTROLS SHIFTING AND/OR READING OUT OF SPECIFICATIONS. IT WAS FOUND THAT THERE IS GREATER ADHERENCE OF THE CYCLOSPORINE/MICROPARTICLE-CYCLOSPORINE COMPLEX TO THE RV WALL FOR RVS MADE USING THE RESIN FROM THE NEW VENDOR VERSUS THE RESIN RVS FROM THE FORMER VENDOR. THE INVESTIGATION ALSO FOUND THAT THE RESIN RV LOT TO LOT VARIABILITY OF THE NEW VENDOR IS NOT CAUSING ASSAY PERFORMANCE ISSUES AND THAT THE RESIN CHANGE DID NOT CAUSE SAMPLE CONCENTRATION SHIFTS IN CUSTOMER DATA. CUSTOMERS HAD BEEN INFORMED BY PRODUCT CORRECTION LETTER (B)(4) TO ONLY USE RV LOTS MANUFACTURED WITH THE SAME RESIN FOR THE ARCHITECT CYCLOSPORINE ASSAY. IF THESE INSTRUCTIONS ARE FOLLOWED, ASSAY PRECISION IS RESTORED TO WITHIN PACKAGE INSERT CLAIMS. PER CURRENT PRODUCT AVAILABILITY, ONLY THE NEW VENDOR RESIN IS NOW BEING MANUFACTURED AND USED EXCLUSIVELY FOR REACTION VESSEL PRODUCTION. SINCE USING THE REACTION VESSELS MANUFACTURED WITH THE NEW RESIN FORMULATION, THE CALIBRATION CURVE IS SLIGHTLY FLATTER, WHICH RESULTS IN HIGHER %CVS THAN PREVIOUSLY OBSERVED WITH THE ASSAY, BUT STILL WITHIN PRECISION CLAIM OF LESS THAN 15 %. THE ARCHITECT CYCLOSPORINE ASSAY WILL BE INCLUDED IN FUTURE TESTING OF ANY RESIN CHANGES. IMPROVEMENT EFFORTS ARE ONGOING AND PLANNED TO BE FINALIZED FOURTH QUARTER 2013.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ARCHITECT CYCLOSPORINE ASSAY RESULT FOR ONE HEART TRANSPLANT PATIENT GENERATED A FALSELY DECREASED RESULT. A PHYSICIAN STATED THAT THE PATIENT'S RESULT WENT FROM 300 UG/L TO 100 UG/L IN TWO DAYS. THERE IS NO REPORT OF ANY IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28061 ARCHITECT CYCLOSPORINE MKW ABBOTT LABORATORIES 16054M500

    Patients

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