BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC PARADIGM

    MDR report key: 411880 · Received July 2, 2002

    Report

    Report Number
    MW4003329
    Date Received
    July 2, 2002
    Date of Event
    June 16, 2002
    Report Date
    July 2, 2002
    Manufacturer
    MEDTRONIC MINIMED INC.
    Product Code
    LZG
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT USED THE PRODUCT FOR DIABETES CONDITION. THEY DID NOT DISCONNECT FROM THE MACHINE AS INSTRUCTED BY THE PRODUCT DIRECTIONS WHEN RE-FILLING THE RESERVOIR WITH INSULIN. AS THEY WERE FILLING THE RESERVOIR THE MACHINE INJECTED THE ENTIRE AMOUNT OF INSULIN INSTEAD SMALL CONTINUOUS AMOUNT OF INSULIN. THE PT WAS TAKEN TO HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PARADIGM INSULIN PUMP LZG MEDTRONIC MINIMED INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR