BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 2004012 · Received February 23, 2011

    Report

    Report Number
    MW5019572
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 23, 2011
    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

    OMNIPOD INSULIN POD FAILED AND ALARMED DURING USE AT 2:13 PM ON DATE IN QUESTION. POD'S LIFE EXPECTANCY IS 72 HRS; HOWEVER, DEVICE FAILED AFTER APPROXIMATELY 31 HRS OF USE. ERROR CODE 19-052-0000-00148. (SAME PT AS MW5019525 AND MW5019526.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN MANAGEMENT SYSTEM OMNIPOD INSULIN POD LZG INSULET CORP L30381

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability