BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1295829 · Received January 16, 2009

    Report

    Report Number
    3004464228-2009-00035
    Event Type
    Other
    Date Received
    January 16, 2009
    Date of Event
    December 25, 2008
    Report Date
    December 25, 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 PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE CUSTOMER STATED THAT A KINK WAS NOTED IN THE CANNULA. THERE WAS NO REPORT OF AN ALARM, HOWEVER, THE POD WOULD HAVE INITIATED AN OCCLUSION ALARM IF THE FLOW OF INSULIN WAS RESTRICTED/PREVENTED BY THE KINK AND RESULTED IN BACK PRESSURE. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO "CHECK INFUSION SITE FREQUENTLY FOR PROPER CANNULA PLACEMENT". IT ALSO SUGGESTS THAT THE USER CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY SO THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE PATIENT REMEDIED THE SITUATION BY REMOVING AND REPLACING THE DEVICE PER USER INSTRUCTIONS.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED TO REPORT THAT SHE DID NOT THINK HER DAUGHTER'S POD WAS WORKING PROPERLY. CUSTOMER'S MOTHER STATED THAT HER DAUGHTER HAS HAD ELEVATED BLOOD GLUCOSE LEVELS (BG'S) ALL DAY. HER BG'S FLUCTUATED BETWEEN 151-456 MG/DL WHILE ALSO INGESTING CARBOHYDRATES. CUSTOMER'S MOTHER STATED HER DAUGHTER WORE THE POD FOR ABOUT 22 HOURS BEFORE SHE DEACTIVATED THE POD. CUSTOMER'S MOTHER STATED THAT THERE WAS BLOOD AROUND THE SITE AND THE CANNULA WAS BENT WHEN THE POD WAS REMOVED. CUSTOMER WAS ABLE TO ACTIVATE A NEW POD. NO FURTHER 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 L11856

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other