BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2843690 · Received October 26, 2012

    Report

    Report Number
    3004464228-2012-00532
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 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 RETURNED DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED. THE CANNULA WAS FULLY DEPLOYED AND THE FIRING MECHANISM PERFORMED AS INTENDED WHEN RELOADED AND REFIRED. NO MANUFACTURE DEFECT, MALFUNCTION OR OTHER PRODUCT CONDITION THAT WOULD RESULT IN A FAILURE TO DELIVER INSULIN AND CONTRIBUTE TO HYPERGLYCEMIA WAS FOUND. THE CUSTOMER REPORTED THAT SHE THOUGHT THE CANNULA MAY NOT HAVE FULLY INSERTED INTO THE INFUSION SITE. THIS CONDITION CANNOT BE CONFIRMED OR EXCLUDED THROUGH LABORATORY TESTING. 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, "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," AND "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." QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN SHE DEACTIVATED THE POD AND REMOVED IT, SHE NOTICED THAT THE CANNULA WAS "ATTACHED TO THE ADHESIVE." SHE BELIEVED IT HAD NOT DEPLOYED COMPLETELY IN THE SKIN AT THE INFUSION. SHE STATED SHE HAD HIGH BLOOD GLUCOSE FOR ABOUT 24 HOURS; HISTORY AS FOLLOWS:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30892

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR