BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3072991 · Received April 5, 2013

    Report

    Report Number
    3004464228-2013-00307
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE KINKED CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER'S GUIDE WARNS "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS 'HIGH CHECK FOR KETONES!' THIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). IF YOU GET A 'HIGH CHECK FOR KETONES!' READING AND FEEL SYMPTOMS SUCH AS FATIGUE, THIRST, EXCESS URINATION, OR BLURRY VISION, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPERGLYCEMIA."

    Description of Event or Problem · 1

    THE CUSTOMER ACTIVATED THE POD AT 6:38 AM AND AT 7:17 AM HIS BLOOD GLUCOSE WAS 182 MG/DL AND HE HAD A MEAL CONTAINING ABOUT 76 GRAMS OF CARBOHYDRATE. NO MEAL BOLUS WAS REPORTED. HIS BG MEASURED 358 MG/DL AT 10:02 AM, "HIGH" (>500 MG/DL) AT 10:43 AM. AT 11:23 AM HIS BG WAS 497 MG/DL, SO HE DEACTIVATED THE DEVICE AT 11:26. THE CANNULA WAS "KINKED TO THE LEFT." TWO AND A HALF HRS AFTER PLACING A NEW POD HIS BG WAS 195 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141882 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L6182

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR