BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 450373 · Received March 21, 2003

    Report

    Report Number
    MW1027967
    Event Type
    Malfunction
    Date Received
    March 21, 2003
    Date of Event
    March 21, 2003
    Report Date
    March 21, 2003
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER HAS BEEN USING A MINIMED INSULIN INFUSION PUMP FOR 11 YEARS. REPORTER CURRENTLY HAS THE MEDTRONIC MINIMED 508 PUMP. REPORTER HAS HAD PROBLEMS WITH IT SINCE THEY FIRST GOT THIS MODEL. IT CONTINUALLY FAILS FOR "ELECTROSTATIC REASONS". REPORTER JUST HAD A PROBLEM AGAIN THIS EVENING. REPORTER HAS HAD THIS MODEL FOR ALMOST 3 YEARS AND TOMORROW THEY WILL BE SENDING THEM THEIR 5TH PUMP. IT IS WARRANTIED FOR 4 YEARS BUT IF THEY HAVE NO CONFIDENCE IN THE PUMP IT IS PRETTY USELESS. FIRST THEY CLAIMED THAT IT WAS BECAUSE OF THE LEATHER CASE AND THEY GAVE THEM A NEW CASE, BUT OBVIOUSLY THAT DIDN'T HELP. REPORTER THINK'S IT IS A PROBLEM WITHIN THE PUMP AND THEY SHOULD FIX THEM OR RECALL THEM AND ISSUE DIFFERENT PUMPS TO THE 508 USERS. REPORTER IS GETTING VERY FRUSTRATED WITH THE CO, BECAUSE REPORTER HAS WRITTEN THEM AND SPOKEN WITH SEVERAL OF THEIR REPS AND GET NO WHERE. SINCE MINIMED WAS PURCHASED BY MEDTRONIC THE CO HAS DRASTICALLY CHANGED AND THEY DON'T CARE ABOUT THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED 508 INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED 508 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other