BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1617132 · Received February 22, 2010

    Report

    Report Number
    3004464228-2010-01059
    Event Type
    Other
    Date Received
    February 22, 2010
    Date of Event
    January 11, 2010
    Report Date
    January 23, 2010
    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 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 CUSTOMER STATED THAT A KINK WAS NOTED IN THE CANNULA. THERE WAS, HOWEVER, NO REPORT OF AN OCCLUSION ALARM. THE POD WOULD HAVE INITIATED AN OCCLUSION ALARM IF THE FLOW OF INSULIN WAS RESTRICT/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 SHOULD CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY IN ORDER TO 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

    THE CUSTOMER'S MOTHER REPORTED THAT HER SON EXPERIENCED A HIGH BG READING (371MG/DL) WHILE WEARING THE POD. A KINK WAS SEEN IN THE CANNULA, WHICH SHE BELIEVES OCCURRED AS A RESULT OF SCAR TISSUE PRESENT AT THE INSERTION SITE. DESPITE THE KINK, NO POD ALARM WAS INITIATED. THE POD WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30228

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other