BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD

    MDR report key: 3020725 · Received March 18, 2013

    Report

    Report Number
    MW5029444
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    March 17, 2013
    Report Date
    March 18, 2013
    Manufacturer
    INSULET CORP
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    OMNI INSULIN POD KEEPS MALFUNCTIONING. DIAGNOSIS OR REASON FOR USE: INSULIN DEPENDANT DIABETIC. DOSE OR AMOUNT: 10 UNITS; FREQUENCY: VARIES; ROUTE: IV BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111802 OMNIPOD INSULIN DELIVERY SYSTEM LZG INSULET CORP UST 200

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| O