BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 1673504 · Received May 2, 2010

    Report

    Report Number
    MW5015804
    Event Type
    Malfunction
    Date Received
    May 2, 2010
    Date of Event
    February 5, 1954
    Report Date
    May 2, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM EXPERIENCING SIMILAR PROBLEMS WITH MY CURRENT MEDTRONIC INFUSION SETS AS WITH "LOT 8". I HAVE JUST ATTEMPTED TO INSERT THE FOURTH ONE TODAY. I AM HOPING THIS ONE WILL SUCCESSFULLY DELIVER INSULIN. MY BLOOD SUGAR THIS MORNING WAS 97 WHEN I NEEDED TO REPLACE THE SET. IT IS NOW 357. EACH SET I HAVE APPLIED HAS BENT AND THE ALARM ON MY PUMP HAS TAKEN A FEW HOURS EACH TIME BEFORE SOUNDING TO MAKE ME AWARE OF THE SITUATION. I OCCASIONALLY HAVE THE TUBING BEND AND STOP THE PUMP FROM DELIVERING BUT, HAVE NOT HAD SO MANY BEND IN A ROW SINCE I WAS USING LOT 8 AND WAS UNAWARE UNTIL THE RECALL THAT THEY WERE FAULTY. CAN YOU PROVIDE ME WITH INFORMATION AS TO WHETHER OR NOT MEDTRONIC HAS TAKEN CORRECTIVE ACTION IN RESPONSE TO THE RECALL? HAVE THERE BEEN OTHER INCIDENTS REPORTED SINCE THE RECALL? I HAVE HAD SIMILAR EVENTS THAT MADE ME QUESTION THE QUALITY OF INFUSION SETS, THIS TIME I FELT I NEEDED TO REPORT IT. I AM CURRENT USING MEDTRONIC QUICK-SET PARADIGM LOT 9201037. (B) (6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC QUICK-SET PARADIGM FPA MEDTRONIC MINIMED 23" 9201037

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other