BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3941035 · Received April 24, 2014

    Report

    Report Number
    3004464228-2014-00530
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 27, 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 DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THE CUSTOMER REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT QUALIFICATIONS RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER WOKE UP WITH A BLOOD GLUCOSE OF 400 MG/DL AND WAS THROWING UP. THE CUSTOMER'S MOTHER GAVE HER MANUAL SHOTS OF INSULIN. UPON INSPECTION OF THE POD, IT WAS NOTICED THAT THE CANNULA HAD DISLODGED FROM THE INSERTION SITE. THE POD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248224 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR