BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC MINIMED PARADIGM QUICK-SET INFUSION SETS

    MDR report key: 1413876 · Received July 9, 2009

    Report

    Report Number
    MW5011886
    Event Type
    Death
    Date Received
    July 9, 2009
    Date of Event
    May 19, 2009
    Report Date
    July 9, 2009
    Manufacturer
    MEDTRONIC INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS USING A MEDTRONIC PARADIGM MINIMED PUMP FOR TREATMENT OF TYPE 1 DIABETES. AFTER A HOSPITALIZATION IN 2008 AND IN EARLY 2009, WE WERE TOLD THAT HIS ABDOMINAL AREA COULD BE BECOMING INSULIN RESISTANT AND TO USE OTHER INFUSION SITES. PT CHANGED INFUSION SITES AS DIRECTED AND SAW HIS ENDOCRINOLOGIST THE NEXT DAY. APPROX FOUR MONTHS LATER, PT WAS FOUND DEAD IN HIS HOME. CORONER HAS RULED THE DEATH A RESULT OF SEQUEL DIABETES MELLITUS. TWO BOXES OF ADDITIONAL SUPPLIES WERE DONATED TO THE DIABETES ASSOCIATION. TWO MONTHS LATER, WE RECEIVED A NOTIFICATION FROM MEDTRONIC THAT THEY WERE ISSUING AN URGENT MEDICAL DEVICE RECALL FOR QUICK SET INFUSION SETS, MODELS MMT399 - LOTS STARTING WITH 8. WE OPENED 2 BOXES OF SUPPLIES AND FOUND THAT THEY WERE IN THE LOT NUMBER SPECIFIED. DOSE OR AMOUNT: NEW INFUSION. FREQUENCY: EVERY 3 DAYS. DATES OF USE: 2008 - 2009. DIAGNOSIS: TYPE 1 DIABETES. DAILY TREATMENT OF INSULIN DELIVERY THROUGH MEDTRONIC MINIMED PARADIGM INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM QUICK-SET INFUSION SETS MINIMED PARADIGM QUICK-SET INFUSION SETS FPA MEDTRONIC INC MMT-399 8200812

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death