BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3820706 · Received May 1, 2014

    Report

    Report Number
    3004464228-2014-00580
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE USER REPORTED A DISLODGED CANNULA. THIS CONDITION WOULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA IF IT OCCURRED. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO QUALIFICATION RECORDS WERE REVIEWED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE REALIZED THE CANNULA HAD COME OUT OF THE INFUSION SITE AFTER WEARING POD FOR 48 HOURS AND HER BLOOD GLUCOSE WAS READING OVER 500 MG/DL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262491 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR