BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1553703 · Received December 3, 2009

    Report

    Report Number
    3004464228-2009-00967
    Event Type
    Other
    Date Received
    December 3, 2009
    Date of Event
    November 4, 2009
    Report Date
    November 4, 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 EVALUATION IS POSSIBLE AT THIS TIME. 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 THAT 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

    CUSTOMER REPORTED EXPERIENCING HIGH BGS (260-380 MG/DL) WHILE WEARING THE POD FOR 24 HOURS. CUSTOMER REPORTED THAT "THE NEEDLE INSERTED ON POD BUT DID NOT INSERT ALL THE WAY AND DID NOT LEAVE THE CANNULA", CUSTOMER DID NOT REALIZED THIS SITUATION UNTIL AFTER WEARING THE POD FOR 24 HOURS. THE POD 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 L30169

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other