BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3150256 · Received May 29, 2013

    Report

    Report Number
    3004464228-2013-00504
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 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 DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED MALFUNCTION OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. THE CUSTOMER REPORTED THAT THE NEEDLE DID NOT DEPLOY PROPERLY, AND THE CANNULA DID NOT INSERT INTO THE SKIN. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. 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." 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." IT ALSO WARNS, "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." LOT QUALIFICATION RECORDS WERE NOT REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE ACTIVATED A POD AT 10:00 PM ON (B)(6). AT 2:00 AM, HER BLOOD GLUCOSE RESULT WAS 400 MG/DL. AT 6:00 AM, IT WAS 454 MG/DL. SHE STATED THAT SHE GAVE HERSELF A 12 UNIT BOLUS AND FELT INSULIN RUNNING DOWN HER ARM. SHE REMOVED THE POD AND NOTICED THAT THE CANNULA WAS NOT IN HER SKIN. SHE SAID THAT THE NEEDLE DID NOT COME OUT OF THE POD FAR ENOUGH TO PENETRATE THE SKIN. SHE DISCARDED THE POD AND ACTIVATED A NEW ONE, AND HER BLOOD GLUCOSE LEVEL WENT DOWN WITH THE NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233742 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR