BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2243651 · Received July 27, 2011

    Report

    Report Number
    3004464228-2011-00377
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFORMATION, IT APPEARS THE CANNULA WAS BENT OR KINKED WHICH COULD HAVE RESTRICTED INSULIN FLOW AND CONTRIBUTED TO THE PATIENT'S HIGH BGS. BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION, A DEVICE MALFUNCTION OR DEFECT CANNOT BE CONFIRMED. THE USER GUIDE ADVISES CUSTOMERS TO CHECK BLOOD GLUCOSE LEVELS FREQUENTLY TO AVOID PROBLEMS SUCH AS HYPERGLYCEMIA. THE LOT NUMBERS WERE NOT PROVIDED, AND THEREFORE, COULD NOT BE EVALUATED.

    Description of Event or Problem · 1

    HCP CALLED ON CUSTOMER'S BEHALF TO REPORT HIGHER THAN NORMAL BG LEVELS ALTHOUGH NO EXACT LEVELS WERE PROVIDED. HCP ALSO STATED THAT THE CANNULA APPEARED TO BE BENT OR KINKED AND THAT THE POD DID NOT ALARM. THE PRODUCT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR