BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 522777 · Received April 12, 2004

    Report

    Report Number
    MW1031669
    Event Type
    Injury
    Date Received
    April 12, 2004
    Date of Event
    April 2, 2004
    Report Date
    April 12, 2004
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT BEGAN USING THE MEDTRONIC MIMIMED PARADIGM QUICK-SET PLUS INFUSION SETS FOR THEIR PARADIGM INSULIN PUMP. THEY PHONED MEDTRONIC CUSTOMER SUPPORT WHEN THEY INITIALLY USED THE NEW INFUSION SET TO MAKE SURE THEY WERE USING IT CORRECTLY, IT DID NOT SEEM RIGHT TO THEM, AND TO ASK FOR THEM TO REPLACE THE QUICK SETS WITH THE SILIOUETTE, WHICH IS WHAT PT USED SUCCESSFULLY PRIOR TO THE QUICK SET. THEY INFORMED PT THEY WOULD NOT CHANGE OUT ANY OPENED BOXES, ONLY UNOPENED BOXES, THEREFORE PT KEPT USING WHAT THEY HAD BEEN SENT, AS THEY HAD OPENED THE BOXES. PT'S SUGARS WERE RUNNING HIGH, AND PT CHANGED OUT THE INFUSION SET TO MAKE SURE THERE WAS NOT A PROBLEM WITH IT, HOWEVER ON THE MORNING OF EVENT DATE PT'S SUGAR WAS 366 AND PT WAS NOT FEELING WELL. PT CANCELLED WORK AND GOT IN BED AND CONTINUED TO BOLUS PUMP, HOWEVER SUGAR CONTINUED TO RISE INTO THE 400S. PT CHANGED INFUSION SET AGAIN AND ADMINISTERED A SHOT OF HUMALOG INSULIN, WHICH TEMPORARILY BROUGHT SUGAR DOWN INTO THE 200S, HOWEVER PUMP NEVER GAVE PT AN ERROR MESSAGE AND PT CONTINUED TO USE IT. SUGAR WAS 495 BY 4:00 P.M. AND PT STARTED TO HAVE SIGNS OF RESPIRATORY DISTRESS AND HEART FAILURE. PT PHONED 911 AND WAS ADMITTED TO HOSP W/KETOACIDOSIS. PT SPENT 6 DAYS IN THE HOSP TO RULE OUT ANY OTHER PROBLEMS. PT FEELS VERY STRONGLY THAT THE PUBLIC SHOULD BE MADE AWARE OF THE POSSIBLE LETHAL HAZARDS ASSOCIATED WITH THIS DEVICE. PT WAS NEVER SENT A LETTER FROM MEDTRONIC EXPLAINING ANY POTENTIAL PROBLEM. PT CHECKED SITE TODAY AND DID NOT SEE ANY MENTION OF THIS PROBLEM. PT FEELS DEVICE SHOULD NOT BE USED AND SHOULD BE RECALLED. LUCKILY PT IS AN EDUCATED CONSUMER AND HAS BEEN A HEALTHY DIABETIC FOR THE PAST 42 YEARS. THIS NEARLY KILLED THEM. PT IS CONCERNED THAT OTHER LIVES ARE IN JEOPARDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM QUICK-SET PLUS INFUSION SET FPA MEDTRONIC MINIMED * 326431

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L