BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1012283 · Received March 12, 2008

    Report

    Report Number
    3004464228-2008-00013
    Event Type
    Other
    Date Received
    March 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 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 IN THE REPORTED INCIDENT WILL NOT BE RETURNED TO THE MFR FOR EVALUATION. UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THIS COMPLAINT WILL BE CONSIDERED COMPLETE AND CLOSED. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO CHECK INFUSION SITE OFTEN 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.

    Description of Event or Problem · 1

    FATHER CALLED FOR HIS SON WHO USES THE SYSTEM. HE SAID THEY PUT A POD ON HIM BEFORE SCHOOL. AROUND 12 NOON THE SCHOOL NURSE CALLED TO SAY THE CHILD'S BG WAS OVER 400. THEY REMOVED THE POD AND NOTED THAT THE CANNULA DIDN'T INSERT. THE POD WAS THROWN AWAY AND IS IS NOT AVAILABLE FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other