BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM 511

    MDR report key: 510867 · Received January 29, 2004

    Report

    Report Number
    MW1030992
    Event Type
    Injury
    Date Received
    January 29, 2004
    Date of Event
    January 29, 2004
    Report Date
    January 29, 2004
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INSULIN PUMP STOPPED WORKING WITH "E13" ALARM MEANING STATIC ELECTRICITY, ACCORDING TO REP. APPEARS TO BE COMMON PROBLEM. HAPPENED WITH A DIFFERENT PUMP 5 DAYS LATER THAT WAS REPLACED AFTER THAT INCIDENT. COMPANY NOT ADMITTING CHRONIC PROBLEM WITH STATIC. COULD POSE SERIOUS PROBLEM IF NOT ABLE TO GET TO INSULIN. PT FEELS CO SHOULD FIX PROBLEM IN ALL MODELS AND INFORM ALL CUSTOMERS. COMPANY WEB SITE PROVIDES NO INFO FOR CUSTOMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM 511 INSULIN PUMP LZG MEDTRONIC MINIMED PARADIGM 511 *
    2 PARADIGM 511 INSULIN PUMP LZG MEDTRONIC MINIMED PARADIGM 511 *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention