BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2243652 · Received July 27, 2011

    Report

    Report Number
    3004464228-2011-00379
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 25, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION. NO PRODUCT MALFUNCTION COULD BE DETERMINED THAT WOULD HAVE CONTRIBUTED TO THE PATIENT'S HIGH BLOOD GLUCOSE LEVELS. THE CANNULA PULLING LOOSE FROM THE SKIN AS REPORTED BY THE CUSTOMER WOULD CONTRIBUTE TO INTERRUPTED INSULIN DELIVERY AND HYPERGLYCEMIA. THE USER GUIDE WARNS "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IT IS ALSO A GOOD IDEA TO CHECK YOUR BLOOD GLUCOSE ABOUT 2 HRS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT. THE LOT WAS FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT CANNULA SLIPPED OUT OF SKIN WHILE WEARING POD. HE REPORTED BG LEVELS OF APPROXIMATELY 440 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30212

    Patients

    Seq Age Sex Outcome Treatment
    1