BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3000087 · Received February 6, 2013

    Report

    Report Number
    3004464228-2013-00093
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 7, 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

    RETURNED DEVICE WAS EVALUATED, AND THE PRODUCT PERFORMED AS DESIGNED DURING TESTING. NO DEFECT THAT WOULD HAVE CAUSED THE CANNULA NOT TO INSERT PROPERLY OR THE PUMP TO FAIL TO DELIVER INSULIN WAS FOUND. THE CUSTOMER REPORTED THAT HE WAS NOT SURE IF THE CANNULA HAD INSERTED. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. IT CANNOT BE CONFIRMED NOR EXCLUDED THROUGH LABORATORY INVESTIGATION. THE OMNIPOD 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 TWO HOURS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT." IT ALSO WARNS, "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." LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER ACTIVATED THE POD ON 5:36AM, AND AT 5:37AM HIS BLOOD GLUCOSE WAS 103 MG/DL. AT 6:44AM, HE CONSUMED 49 GRAMS OF CARBOHYDRATES AND TOOK A 3.25U BOLUS. AT 9:15AM, HIS BLOOD GLUCOSE WAS 499 MG/DL, WHICH HE CORRECTED WITH A MANUAL INJECTION. AT 9:37 AM, HE REMOVED THE POD BECAUSE HE SUSPECTED THE CANNULA MAY NOT HAVE GONE INTO HIS SKIN SINCE HE DID NOT FEEL ANYTHING GO IN AND HIS BLOOD GLUCOSE WAS HIGHER THAN USUAL. HE STATED THAT THE CANNULA WAS CURVED WHEN HE REMOVED THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49977 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30988

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR