BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE

    MDR report key: 2588226 · Received May 25, 2012

    Report

    Report Number
    1415939-2012-00218
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Report Date
    May 2, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MKW
    PMA / PMN Number
    K080751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ACCURACY TESTING WAS PERFORMED TO ASSESS THE PERFORMANCE OF THE ARCHITECT CYCLOSPORINE ASSAY LOT 11074M500. RESULTS OF THIS TESTING PROTOCOL SHOWED THAT THE ACCEPTANCE CRITERIA WERE MET. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT CYCLOSPORINE PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE OF DISCREPANT RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THEIR ARCHITECT CYCLOSPORINE RESULTS ARE LOWER THAN RESULTS FROM ANOTHER FACILITY ((B)(6)). A PATIENT SAMPLE GENERATED A CYCLOSPORINE RESULT OF 70 NG/ML. THE SAMPLE WAS TESTED AT THE (B)(6) AND A RESULT OF 100 NG/ML WAS GENERATED. THE PATIENT'S PREVIOUS CYCLOSPORINE RESULTS WERE: ON 12/13/2011 75.9 NG/ML, 1/12/2012 120 NG/ML, 3/06/2012 89 NG/ML, 4/24/2012 57.2 NG/ML. THE CYCLOSPORINE RESULTS FROM THE DRESDEN FACILITY WERE: ON 10/10/2011 112 NG/ML, 01/23/2012 105 NG/ML, 04/11/2012 101 NG/ML. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CYCLOSPORINE MKW ABBOTT LABORATORIES 11074M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000 ANALYZER: LN 3M74-02| SN (B)(4)| ARCHITECT I2000 ANALYZER: LN 3M74-02| SN (B)(4)