BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3023070 · Received February 26, 2013

    Report

    Report Number
    3004464228-2013-00168
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 26, 2013
    Report Date
    January 27, 2013
    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 INVESTIGATED AND PERFORMED AS DESIGNED. NO DEFECT OR DEFICIENCY THAT WOULD RESULT IN THE CANNULA FALLING TO INSERT CORRECTLY OR THE PUMP FAILING TO DELIVER INSULIN WERE FOUND. THE CUSTOMER REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. IT CANNOT BE CONFIRMED NOR EXCLUDED THROUGH LABORATORY EVALUATION. THE OMNIPOD USER GUIDE WARNS "CHECK OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY ATTACHED AND IN PLACE. A LOOSE OR DISLODGE CANNULA MAY INTERRUPT INSULIN DELIVERY," AND "BECAUSE INSULIN POD 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." QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE ACTIVATED THE DEVICE AT 1:40 AM AND HIS BLOOD GLUCOSE, CARBOHYDRATE AND INSULIN TREATMENT THE NEXT DAY WERE AS FOLLOWS: TIME: 7:55 AM, BG (MG/DL): 171, CHO (G), BOLUS (U): 1.05. TIME: 11:02 AM, BG (MG/DL): 130, CHO (G): 69, BOLUS (U): 4.35. TIME: 3:05, BG (MG/DL): 193, CHO (G): 33, BOLUS (U): 3.60. TIME: 5:15 PM, BG (MG/DL): 370, CHO (G): 45, BOLUS (U): 6.55. HE NOTICED THAT THE CANNULA WAS OUT OF SKIN CAUSING LEAKAGE AND DEACTIVATED THE POD AT 7:48 PM. THE CANNULA WAS ALSO KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82859 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31014

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR