BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC MINI MED

    MDR report key: 774893 · Received October 26, 2006

    Report

    Report Number
    MW1040814
    Event Type
    Other
    Date Received
    October 26, 2006
    Date of Event
    December 10, 2003
    Report Date
    October 26, 2006
    Manufacturer
    MEDTRONIC MIN MED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CURRENTLY I AM USING A MINI-MED PARADIGM INSULIN PUMP AND HAVE BEEN SINCE 2002. SINCE THEN I HAVE CONTINUALLY BEEN HAVING PROBLEMS WITH CRACKS IN THE PLASTIC CASING OF THE PUMP. MINI-MED REPLACED ONE IN 2003 FOR CRACKS. AGAIN IN 2004, 2005, 2 MOS LATER IN 2005, 2006, TWO MOS LATER IN 2006 AND TODAY I CONTACTED THEM BECAUSE THE ONE THAT I AM CURRENTLY USING HAS SEVERE CRACKS AND PROBABLY IS THE WORST OF THOSE THAT I HAVE SENT BACK AND THEIR ANSWER, WITH MUCH PERSUASION, IS TO SEND ME ANOTHER PUMP EVEN THOUGH MINE IS OUT OF WARRANTY. I HAVE NEVER ONCE DROPPED ONE OF THESE. I AM ON DISABILITY SO THEREFORE I'M NOT ABUSING THEM AND I HAVE NEVER WORN IT IN THE SHOWER OR IN THE WATER. AT THIS POINT, I AM REALLY FRUSTRATED AND NEED TO KNOW WHY THIS IS HAPPENING AND THEY HAVE YET TO SEND ME AN ANALYSIS OF WHAT THEY FIND WHEN I RETURN THEM, AS THEY HAVE ALWAYS TOLD ME THAT THEY WOULD. I AM THOROUGHLY CONVINCED THAT SOMETHING MUST BE WRONG WITH THIS PRODUCT. THEIR ANSWER IS ALWAYS THAT I AM THE ONLY ONE HAVING THIS PROBLEM. I REALLY HAVE A HARD TIME BELIEVING THIS. IF THIS HAD HAPPENED ONLY ONCE, I COULD UNDERSTAND THAT IT MIGHT BE A FLUKE THING BUT 7 TIMES IN A PERIOD OF 3 YEARS IS A BIT MUCH! AS YOU KNOW THIS IS AN EXTREMELY IMPORTANT DEVICE, NECESSARY IN CONTROLLING MY DIABETES. PLEASE HELP ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINI MED PARADIGM INSULIN PUMP LZG MEDTRONIC MIN MED MMT-515NAL *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other