BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 510603 · Received January 29, 2004

    Report

    Report Number
    MW1030991
    Event Type
    Injury
    Date Received
    January 29, 2004
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEW MEDTRONIC MINIMED INFUSION SETS ARE NOT MEETING STANDARDS. THERE IS DIFFICULTY INSERTING THE NEW SET, CAUSING KINKED CANNULAS, CAUSING NO DELIVERY OF INSULIN LEADING TO HIGH BLOOD SUGARS, DIABETIC KETOACIDOSIS AND POSSIBLE DEATH. THE PTS ARE ALSO REPORTING INCREASED PAIN AND THE NEED TO REPLACE THE INFUSION SET FREQUENTLY DUE TO THIS PAIN. OF THE 5 PTS THAT HAVE RECEIVED THIS PRODUCT, NONE HAVE HAD SUCCESS, 2 HAVE SWITCHED TO OTHER PROBLEMS, 2 ARE STILL TRYING TO "IMPROVE TECHNIQUE" WHICH IS WHAT MEDTRONIC MINIMED HAS TOLD THEM TO DO. RPTR IS UNAWARE OF ANY PROBLEMS WITH THE OLD PRODUCT AND THERE WERE NO COMPLAINTS OF PAIN. ONE PT IS CONSIDERING GOING OFF OF THE PUMP AND BACK ON INJECTIONS BECAUSE OF THE PAIN.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 1/27/04: RECENTLY, MEDTRONIC MINIMED REPLACED THE QUICK SET INFUSION SET WITH A NEW QUICK SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED NEW QUICK SET INFUSION SET FOZ MEDTRONIC MINIMED ALL NEW QUICK SET IN *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R INSULIN PUMP