BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 516075 · Received March 2, 2004

    Report

    Report Number
    MW1031404
    Event Type
    Injury
    Date Received
    March 2, 2004
    Date of Event
    February 27, 2004
    Report Date
    March 2, 2004
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC MINIMED DISTRIBUTED TO PAYING CUSTOMERS THE QUICKSET PLUS INFUSION SET FOR USE WITH THE PARADIGM INSULIN PUMP. THIS SET HAS SEVERAL DEFECTS WHICH IF TESTED PROPERLY WOULD HAVE BEEN EASILY IDENTIFIED. THE ADHESIVE DOES NOT STICK TO PT'S SKIN "CREATING" THE CANNULA TO BECOME DISENGAGED PREVENTING FLOW OF INSULIN INTO PTS. THERE IS ALSO A DESIGN FLAW IN THE CANNULA IN WHICH IT IS SO CHEAPLY MADE THAT WHEN INSERTED INTO PT, THE CANNULA BENDS TO A 90 DEGREE ANGLE THEREFORE ALSO PREVENTING FLOW OF INSULIN INTO PT. PT HAS HAD THIS PROBLEM 3 TIMES. THESE ISSUES RESULTED IN INCREASED BLOOD SUGAR LEVELS OF 347, 596, AND 350 GOING UP TO 411. THE ONLY TIME PT HAD A BLOOD SUGAR IN ANY OF THESE RANGES WAS WHEN THEY WERE FIRST DIAGNOSED WITH DIABETES IN 1991. THESE PROBLEMS COULD HAVE BEEN PREVENTED WITH PROPER TESTING OF THIS FDA APPROVED QUICKSET PLUS. THESE BLOOD SUGARS CAN LEAD TO COMA AND DEATH AS WELL AS HOSPITALIZATION AND OTHER LIFE-THERATENING CONDITIONS SUCH AS ORGAN FAILURE. PT HAD TO DISCONTINUE USE OF THESE PRODUCTS AND USE SYRINGES AND INSULIN TO CORRECT THESE HIGH BLOOD SUGARS AND ALSO HAD TO CALL DR'S EXCHANGE FOR FURTHER REMEDY. FORTUNATELY, PT DID NOT END UP IN THE HOSP OR ANYTHING WORSE. PT HAS BEEN REPORTING PROBLEMS WITH THESE DEVICES SINCE THEY FIRST RECEIVED THEM WHICH WAS LATE DECEMBER. THE CO FAILED TO ACKNOWLEDGE ANY "PROBLEMS" WITH THESE DEVICES UNTIL FEBRUARY 27, 2004. PT'S BLOOD SUGARS ARE NORMALLY IN THE RANGE OF 80 TO 120, WHICH ARE NORMAL BLOOD SUGAR RANGES FOR THOSE WITH AND WITHOUT DIABETES. UNTIL THIS NEW QUICKSET PLUS WAS INTRODUCED INTO CIRCULATION, PT'S BLOOD SUGARS WERE NORMAL AND IN EXCELLENT CONTROL WHICH IS VITAL TO CONTINUED HEALTH WHEN YOU HAVE DIABETES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening| R