BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1082947 · Received July 25, 2008

    Report

    Report Number
    3004464228-2008-00148
    Event Type
    Other
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 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 MFR FOR EVAL. UNABLE TO CONFIRM ANY PROD MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE PROD 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

    A CUSTOMER CALLED TO REPORT A POD SHE WAS NOT SURE WAS DELIVERING INSULIN. CUSTOMER STATED THAT SHE PLACED THE POD ON BEFORE BED WHEN HER BG WAS 155. WHEN CUSTOMER WOKE UP HER GB WAS 299. CUSTOMER WAS CONCERNED AS THIS IS QUITE HIGH FOR HER. WHEN SHE REMOVED THE POD, SHE NOTICED THE INSERTION NEEDLE HAD NOT RETRACTED INTO THE POD. 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 L11683

    Patients

    Seq Age Sex Outcome Treatment
    1 Other