BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1172643 · Received September 19, 2008

    Report

    Report Number
    3004464228-2008-00215
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND EVALUATED. IT WAS DETERMINED THAT THE NEEDLE MECHANISM HAD NOT FIRED DUE TO INTERFERENCE FROM A DAMAGED COMPONENT. THE USER FAILED TO NOTE THIS CONDITION WHICH WOULD BE VISIBLE VIA THE VIEWING PORT UPON POD PLACEMENT IF LABELING IS FOLLOWED. THE PRODUCT 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. THE PATIENT NOTED THAT 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 CALLED TO REPORT THE NEEDLE NEVER RETRACTED BACK INSIDE THE POD AND THE CANNULA NEVER INSERTED INTO HER SKIN. SHE WORE THE POD AND DID NOT NOTICE THE PROBLEM UNTIL A LITTLE WHILE LATER WHEN HER BLOOD GLUCOSE (BG) WAS "HIGH". SHE WAS ABLE TO ACTIVATE A NEW POD SUCCESSFULLY AND HER BG STABILIZED TO 118 MG/DL AT TIME OF CALL. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11739

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other