BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD

    MDR report key: 1980032 · Received January 31, 2011

    Report

    Report Number
    MW5019239
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    INSULET CORP.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN USING THE OMNIPOD INSULIN DELIVERY SYSTEM FOR 3 + YEARS. I HAVE HAD 8 PODS THAT HAVE ALARMED AND BEEN USELESS IN THE LAST MONTH. I HAVE REPORTED ALL OF THEM TO PRODUCT SUPPORT AND HAVE RECEIVED NO WORD ON WHAT IS BEING DONE ABOUT THEM. I HAVE HAD TWO INSTANCES WHERE THE POD ON MY BODY ALARMED AND MY BACK-UP POD WHEN I WENT TO SWITCH PODS ALARMED SO I WAS LEFT WITH NO USABLE POD AND WAS AWAY FROM HOME. TODAY I AM AT WORK AND WILL NOT BE ABLE TO REPLACE MY POD FOR ANOTHER 3 HOURS. WHEN I CALL TO REPORT EACH POD I AM TOLD THAT PRODUCT SUPPORT TAKES THE REPORT AND QC LOOKS INTO EACH REPORT, NO ONE HAS EVER CONTACTED ME TO LET ME KNOW WHAT IS BEING FOUND OR DONE. THEY DO NOT TAKE REPORTS ON PODS THAT ALARM FOR OCCLUSION SO THOSE ARE JUST A LOSS TO THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD OMNIPOD LZG INSULET CORP. L30451

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR