BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE

    MDR report key: 3232725 · Received July 18, 2013

    Report

    Report Number
    1415939-2013-00294
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MKW
    PMA / PMN Number
    K080751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    REVIEW OF CUSTOMER INFORMATION; TRACKING AND TRENDING REVIEW. ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THEY INDICATED THAT THE CAUSE OF THE DISCREPANT RESULTS WAS DUE TO THE ADMINISTRATION OF THE CYCLOSPORINE MEDICATION AND THE RESULTS WERE ACCURATE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED FOR THE ISSUE UNDER INVESTIGATION. THE ARCHITECT CYCLOSPORINE REAGENT PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATION MANUAL WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT DISCREPANT ARCHITECT CYCLOSPORINE RESULTS WERE GENERATED. AN INITIAL RESULT OF 600 NG/ML WAS GENERATED. THE SAMPLE WAS RETESTED AND A RESULT OF 680 NG/ML WAS GENERATED. THE FOLLOWING DAY A NEW SAMPLE WAS OBTAINED AND A RESULT OF 120 NG/ML WAS GENERATED. THIS SAMPLE WAS RETESTED AND A RESULT OF 124 NG/ML WAS OBTAINED. FURTHER CYCLOSPORINE RESULTS FROM THE PATIENT WERE AS FOLLOWS. (B)(6). THE CUSTOMER INDICATED THAT THE ISSUE MAY HAVE BEEN DUE TO AN INCREASE IN THE DRIP RATE BY THE ATTENDING NURSE. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334724 ARCHITECT CYCLOSPORINE MKW ABBOTT LABORATORIES 21307M500

    Patients

    Seq Age Sex Outcome Treatment
    1 SN (B)(4)| ARCHITECT I2000 ANALYZER 8C89-01