BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4213633 · Received September 25, 2014

    Report

    Report Number
    3004464228-2014-01445
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 29, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE TO FIRE AND PROPERLY INSERT THE CANNULA OR TO DETERMINE ITS ROOT CAUSE. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CANNULA NEVER INSERTED INTO THE SKIN AND THAT THE CANNULA WAS BENT. THE PINK SLIDE INSERT WAS NOT VISIBLE IN THE VIEWING WINDOW. THE CUSTOMER'S BLOOD GLUCOSE REACHED 550 MG/DL. THE POD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596840 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40527

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR