BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1292244 · Received January 16, 2009

    Report

    Report Number
    3004464228-2009-00033
    Event Type
    Other
    Date Received
    January 16, 2009
    Date of Event
    December 23, 2008
    Report Date
    December 23, 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 DEVICE INVOLVED WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE PRODUCT USER GUIDE INSTRUCTS TO 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 USER FAILED TO NOTE THIS CONDITION WHICH COULD BE VISIBLE VIA THE VIEWING PORT UPON POD PLACEMENT IF LABELING IS FOLLOWED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE NEEDLE ON A POD INSERTED LATE AND AS A RESULT, HIS BLOOD GLUCOSE WENT UP TO 320 MG/DL. THE CUSTOMER STATED HE DID NOT HEAR THE NEEDLE INSERT WHEN HE STATED THE POD, BUT WHEN HE WENT TO BOLUS, THE NEEDLE INSERTED. HE HAD WORN THE POD FOR A FEW HOURS. NO OTHER 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 L30019

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other