BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1295836 · Received January 21, 2009

    Report

    Report Number
    3004464228-2009-00039
    Event Type
    Other
    Date Received
    January 21, 2009
    Date of Event
    December 27, 2008
    Report Date
    December 27, 2008
    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 HAS NOT BEEN RETURNED SO NO EVALUATION 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 VIA THE VIEWING PORT UPON POD PLACEMENT IF LABELING IS FOLLOWED. 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. THE PATIENT REMEDIED THE SITUATION BY REMOVING AND REPLACING THE DEVICE PER USER INSTRUCTIONS. THE LOT WAS FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED BECAUSE HER SON'S BLOOD GLUCOSE LEVELS (BG'S) WERE ELEVATED AND SHE BELIEVES IT WAS DUE TO THE CANNULA NEVER BEING INSERTED. SHE WAS ABLE TO PLACE NEW POD ON HER SON SUCCESSFULLY. NO FURTHER ISSUES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11828

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other