BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2844947 · Received October 24, 2012

    Report

    Report Number
    3004464228-2012-00530
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 25, 2012
    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

    A BENT CANNULA HAS THE POTENTIAL TO RESTRICT INSULIN DELIVERY AND MAY RESULT IN HYPERGLYCEMIA. HOWEVER, SINCE THE POD WAS NOT RETURNED, WE CANNOT CONFIRM ANY PRODUCT MALFUNCTION OR DEFECT THAT MAY HAVE CONTRIBUTED TO THE CUSTOMER'S HYPERGLYCEMIA. THE OMNIPOD'S USER GUIDE WARNS TO "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 TWO HOURS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT." THE USER GUIDE WARNS THAT "TEST RESULTS GRATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA," AND ADVISES TO TREAT HYPERGLYCEMIA FIRST BY CHECKING FOR KETONES. IF KETONES ARE PRESENT, FOLLOW THE GUIDANCE OF AN HCP. IF KETONES ARE NOT PRESENT, TAKE A CORRECTION BOLUS AS PRESCRIBED BY AN HCP. CHECK BLOOD GLUCOSE AGAIN AFTER TWO OURS. IF BG LEVELS HAVE NOT DECREASED THEN TAKE A SECOND BOLUS BY INJECTION, USING A STERILE SYRINGE. IF BGS REMAIN HIGH A TOTAL OF 4 HOURS THEN REPLACE THE POD AND CONTACT AN HCP FOR GUIDANCE. LOT QUALIFICATION RECORDS WERE REVIEWED AND DETERMINED TO HAVE PASSED ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    PRODUCT WAS ACTIVATED JUST BEFORE BED ON (B)(6) 2012 AND BG WAS "IN RANGE" AT THAT TIME. THE NEXT DAY, HE WOKE UP FEELING SICK AND THROWING UP. HIS BG WAS 400 MG/DL+; HE USED THE PDM TO CALCULATE A CORRECTION BOLUS. ABOUT AN HOUR LATER, HIS BG WAS STILL IN 400S MG/DL. HE DEACTIVATED THE POD AND MANUALLY ADMINISTERED INSULIN. MOM STATED THE "CANNULA WAS OBVIOUSLY BENT" WHEN THE POD WAS REMOVED. POD WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSON, INSULIN LZG INSULET CORPORATION 11200 04/01/2014

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR