BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1575003 · Received January 7, 2010

    Report

    Report Number
    3004464228-2010-01016
    Event Type
    Other
    Date Received
    January 7, 2010
    Date of Event
    December 10, 2009
    Report Date
    December 10, 2009
    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 PRODUCT WAS NOT RETURNED, SO NO EVAL IS POSSIBLE. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO "CHECK INFUSION SITE FREQUENTLY FOR PROPER CANNULA PLACEMENT". THE USER FAILED TO NOTE THIS CONDITION WHICH WOULD BE VISIBLE THROUGH THE VIEWING PORT UPON POD PLACEMENT IF LABELING IS FOLLOWED. IT ALSO SUGGESTS THAT THE USER SHOULD CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE PT REMEDIED THE SITUATION BY REMOVING AND REPLACING THE DEVICE PER USER INSTRUCTIONS.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT THE NEEDLE MECHANISM HAD NOT DEPLOYED AND THAT THE CANNULA, THEREFORE, HAD NOT INSERTED. WITHIN FOUR HOURS OF ACTIVATING THIS POD, HIGH BG'S (GREATER THAN 350 MG/DL) WERE EXPERIENCED. NO ADD'L INFO WAS PROVIDED ABOUT THE DEVICE OR THE EVENT. THE POD WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30100

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other