BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 1998790 · Received February 16, 2011

    Report

    Report Number
    MW5019443
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 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

    MULTIPLE FAILURES OF INSULET CORP'S OMNIPOD INSULIN DELIVERY SYSTEM. GREATER THAN 60% FAILURE RATE FOR THE OMNIPOD MEDICAL DEVICE AT PRESENT TIME. INSULET CORP HAS BEEN CONTACTED MULTIPLE TIMES REGARDING THE FAILURE AND AT NO TIME HAS REQUESTED THAT ANY OF THE OMNIPODS BE RETURNED FOR INVESTIGATION AS TO WHY FAILURE RATE HAS BEEN SO EXTENSIVE. THE OMNIPODS HAVE BEEN FAILING AND ALARMING DURING THE INITIAL FILLING OR PRIMING PERIOD OF SYSTEM ACTIVATION PRIOR TO BEING ATTACHED TO THE PT FOR USE. ADDITIONALLY, ONE "REPLACEMENT" OMNIPOD THAT WAS RECEIVED FROM INSULET CORP WAS ALARMING IN THE BOX THAT DELIVERED BY THE PARCEL CARRIER AND HAD NOT EVEN BEEN REMOVED FROM ITS PROTECTIVE PACKAGING. INSULET CORP'S CUSTOMER SERVICE REPS HAVE ADVISED USER TO DISPOSE OF EACH AND EVERY DEFECTIVE PRODUCT EVERY TIME THEY HAVE BEEN INFORMED REGARDING THESE SPECIFIC LOADING AND PRIMING FAILURES. DIAGNOSIS OR REASON FOR USE: (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability