BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2894353 · Received November 16, 2012

    Report

    Report Number
    3004464228-2012-00590
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 19, 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 DEVICE WAS NOT RECEIVED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE KINKED CANNULA OR DETERMINE IF IT COULD HAVE CONTRIBUTED TO REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE 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," AND ADVISES" TO AVOID HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) CHECK YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY (WHEN YOU WAKE UP, BEFORE EACH MEAL, AND BEFORE GOING TO BED)," AND "IT IS ALSO A GOOD IDEA TO CHECK YOUR BLOOD GLUCOSE ABOUT TWO HOURS AFTER EACH POD CHANGE."

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT THE DEVICE WAS ACTIVATED AT 8:53 AM (NO BLOOD GLUCOSE RESULT REPORTED THAT THE TIME). AT 12:22 PM HER SON'S BG MEASURED 400 MG/DL; A 4 UNIT CORRECTION BOLUS WAS GIVEN. AT 1:44 PM HIS BG WAS 403 MG/DL AND ANOTHER 4 UNITS WERE BOLUSED TO CORRECT. AT 1:57 PM, WITH BG OF 400 MG/DL, THE DEVICE WAS DEACTIVATED. SHE STATED THAT THE CANNULA WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30943

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR