BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2010325 · Received February 11, 2011

    Report

    Report Number
    3004464228-2011-00065
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD 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 SEEN 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 RESTRICTED/PREVENTED BY THE KINK AND RESULTED IN BACK PRESSURE. THE OMNIPOD 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BG LEVELS HAD "PEAKED AT A HIGH READING" (GREATER THAN 500MG/DL) WITHIN THE SECOND DAY OF POD WEAR. SHE REPORTED THAT "THE CANNULA WAS KINKED", THOUGH NO ALARM WAS INITIATED BY THE POD. THE DEVICE 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 L30405

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other