BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC - MINIMED

    MDR report key: 5483234 · Received January 18, 2005

    Report

    Report Number
    5483234
    Event Type
    Injury
    Date Received
    January 18, 2005
    Date of Event
    January 11, 2005
    Report Date
    January 13, 2005
    Manufacturer
    MEDTRONIC
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COMMUNICATION WITHIN THE PUMP MALFUNCTIONED AND IT IS BELIEVED THAT ALL INSULIN IN THE PUMP WAS DELIVERED IN THE PRIME MODE (AS MUCH AS 180 UNITS AS PT HAD JUST FILLED RESERVOIR). ONLY 0.7 UNIT OF INSULIN SHOULD HAVE BEEN RECEIVED. PT ADMITTED TO HOSPITAL OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC - MINIMED PARADIGM CSII LZG MEDTRONIC CSII

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization