BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INSULIN, 512 NA SMOKE

    MDR report key: 553219 · Received November 3, 2004

    Report

    Report Number
    2032227-2004-02053
    Event Type
    Injury
    Date Received
    November 3, 2004
    Date of Event
    October 1, 2004
    Report Date
    October 1, 2004
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING HOSPITALIZED WITH HIGH BG AND KETONES. MD ADVISED THEM TO CALL MMI TO RUN A FUNCTIONAL CHECK. CHECKED SETTINGS AND RAN 5 UNITS OF INSULIN. PUMP PASSED AND INSULIN EXITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP, INSULIN, 512 NA SMOKE INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512NAS *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization