BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4232652 · Received September 12, 2014

    Report

    Report Number
    3004464228-2014-01365
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 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 EVAL. THE USER REPORTED A DISLODGED CANNULA. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED HER SON'S BLOOD GLUCOSE, CARBOHYDRATE INTAKE AND INSULIN HISTORY IS AS FOLLOWS: SEE SCANNED TABLE. HE NOTICED THE POD WAS COMING UP TO THE SIDE AND THE CANNULA WAS OUT OF HIS SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563691 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L41153

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR