BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2860142 · Received November 30, 2012

    Report

    Report Number
    3004464228-2012-00616
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 2, 2012
    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 EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND ER VISIT. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS "IF YOU OBSERVE BLOOD IN THE CANNULA, CHECK YOUR BLOOD GLUCOSE MORE FREQUENTLY TO ENSURE INSULIN DELIVERY HAS NOT BEEN AFFECTED. IF YOU EXPERIENCE UNEXPECTED ELEVATED BLOOD GLUCOSE LEVELS, CHANGE YOUR POD," AND "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."

    Description of Event or Problem · 1

    THE PATIENT'S FATHER REPORTED THAT THEY ACTIVATED THE POD ON (B)(6) 2012. ON (B)(6) 2012 HIS SON'S BLOOD GLUCOSE MEASURED 126 MG/DL AT 12:00 AM AND 127 MG/DL AT 3:00 AM. BY 7:47 AM HIS BG HAD RISEN TO 386 MG/DL. THIS WAS CORRECTED WITH A 2.55 UNIT INSULIN BOLUS. AT 7:59 AM HE HAD BREAKFAST ESTIMATED TO CONTAIN 44 GRAMS OF CARBOHYDRATE AND A 3.1 UNIT MEAL BOLUS. AT 10:56 AM THE PATIENT WAS VOMITING AND HAD A BG OF 457 MG/DL. THE FATHER TOOK HIM TO THE EMERGENCY ROOM WHERE THEY MEASURED HIS BG AT 450 MG/DL AND DEACTIVATED THE DEVICE. HE WAS TREATED WITH FLUIDS AND A MANUAL INJECTION OF INSULIN. THE FATHER OBSERVED BLOOD IN THE CANNULA WHEN THE POD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30906

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other