BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1882231 · Received October 20, 2010

    Report

    Report Number
    3004464228-2010-01324
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD INVOLVED WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. THE CUSTOMER REPORTED THAT THE POD "HAD NO CANNULA" - THIS CONDITION COULD RESULT FROM A MANUFACTURING ERROR WHERE THE CANULA ASSEMBLY FAILED TO BE INSTALLED. WITHOUT THE POD RETURNED FOR EVALUATION, HOWEVER, NO DEVICE MALFUNCTION CAN BE CONFIRMED. THE OMNIPOD USER GUIDE INSTRUCTS THE USER TO "CHECK INFUSION SITE FREQUENTLY FOR PROPER CANNULA PLACEMENT". IT ALSO SUGGESTS THAT THE USER SHOULD CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES AND TO ALWAYS CARRY EXTRA SUPPLIES IN CASE OF AN EMERGENCY.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER DAUGHTER "HAD GOTTEN REAL SICK DUE TO NO INSULIN" AND WAS THEREFORE GOING TO BE TAKEN TO THE EMERGENCY ROOM. SHE NOTICED THAT THE POD "HAD NO CANNULA AND ALL INSULIN WAS STILL IN THE POD" AND FIGURED THIS WAS THE REASON FOR HER DAUGHTER'S ILLNESS. SHE ALSO STATED THAT THE POD DID NOT ALARM. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30318

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention