BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INS. DEL. POD 400 SERIES

    MDR report key: 3274143 · Received August 3, 2013

    Report

    Report Number
    MW5031329
    Event Type
    Malfunction
    Date Received
    August 3, 2013
    Date of Event
    July 28, 2013
    Report Date
    August 3, 2013
    Manufacturer
    INSULET CORP.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE INSULET CORP 400 SERIES INSULIN DELIVERY POD (1/3 SMALLER, INTRODUCED JULY 2013) HAD A MECHANICAL FAILURE THAT STOPPED INSULIN DELIVERY AFTER 2 DAYS USAGE. THIS IS FIRST NEW POD I HAVE USED, AND IT FAILED. LOT L40420, ERROR CODE 19-04030-03451-104.(B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364539 OMNIPOD INS. DEL. POD 400 SERIES OMNIPOD POD LZG INSULET CORP. OMNIPOD SERIES 400 L40420

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR