BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1122361 · Received August 15, 2008

    Report

    Report Number
    3004464228-2008-00173
    Event Type
    Other
    Date Received
    August 15, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. 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.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT POD FAILED TO DEPLOY CANNULA AND THAT THE NEEDLE STAYED OUT. HE WOKE UP AT 4AM AND HIS BLOOD GLUCOSE (BG) WAS 450 MG/DL. NO ALARMS SOUNDED ON POD OR PDM. IT WAS AS IF IT WAS WORKING THE WHOLE TIME. NO FURTHER PROBLEMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11804

    Patients

    Seq Age Sex Outcome Treatment
    1 Other