BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2861191 · Received November 2, 2012

    Report

    Report Number
    3004464228-2012-00549
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    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 EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY DEFECT OR MFG DEFICIENCY CONTRIBUTED TO THE REPORTED HIGH BLOOD GLUCOSE. THE CALLER REPORTED THAT THE CANNULA APPEARED TO BE OUT OF THE SKIN AT THE INFUSION SITE WHEN THE POD WAS REMOVED. IF THE CANNULA HAD NOT INSERTED PROPERLY OR HAD DISLODGED, INSULIN DELIVERY WOULD BE INTERRUPTED, CONTRIBUTING TO HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER'S 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 TWO HOURS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT," "CHECK OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY ATTACHED AND IN PLACE. A LOOSE OR DISLODGED CANNULA MAY INTERRUPT INSULIN DELIVERY," AND "BECAUSE INSULIN PODS USE ONLY RAPID-ACTING INSULIN, USERS ARE AT INCREASED RISK FOR DEVELOPING HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) IF INSULIN DELIVERY IS INTERRUPTED. IF IT IS UNTREATED, SEVERE HYPERGLYCEMIA CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA). DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, OR DEATH. IF INSULIN DELIVERY IS INTERRUPTED FOR ANY REASON, YOU MAY NEED TO REPLACE THE MISSING INSULIN - USUALLY WITH AN INJECTION OF RAPID-ACTING INSULIN. ASK YOUR HEALTHCARE PROVIDER FOR INSTRUCTIONS ON HANDLING INTERRUPTED INSULIN DELIVERY."

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT ON (B)(6) 2012 AT 6:45 AM, HER SON'S BLOOD GLUCOSE MEASURED 335 MG/DL. THEY CORRECTED WITH A 7 UNIT INSULIN BOLUS. AT 8:55, AM WHILE AT SCHOOL, HIS BG WAS 389 MG/DL. THE CALLER HAD TO DRIVE A NEW POD TO THE SCHOOL. WHEN THE SUBJECT POD WAS REMOVED, THEY NOTICED THE CANNULA WASN'T IN THE SKIN. THE SUBJECT DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30910

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR