BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2821473 · Received October 24, 2012

    Report

    Report Number
    3004464228-2012-00528
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 23, 2012
    Report Date
    September 23, 2012
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED POD WAS EVALUATED AND FOUND TO BE FUNCTIONING AS INTENDED. DOWNLOADED DATA FOUND NO PULSE WITH TIMEOUTS, NO ROTATIONAL SENSOR ERRORS, AND NO OCCLUSION. THE PIEZO WAS FOUND CAPABLE OF EMITTING AN AUDIBLE ALARM. NO BEND OR KINK WAS FOUND IN THE CANNULA. THE INSPECTION OF THE FLUID PATH FOUND NO EVIDENCE OF AN OBSTRUCTION THAT WOULD HAVE RESULTED IN AN OCCLUSION AS FLUID WAS SEEN EXITING THE TIP OF THE CANNULA. THE NEEDLE MECHANISM WAS TESTED AND DEPLOYED AS INTENDED. THERE WERE NO SIGNS OF AN INTERNAL INSULIN LEAK. THE POD WAS THOROUGHLY INVESTIGATED AND FOUND NO PROBLEM THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE PT'S CONDITION. THE OMNIPOD'S USER GUIDE WARNS,".. IF YOU EXPERIENCE UNEXPECTED ELEVATED BLOOD GLUCOSE LEVELS, CHANGE YOUR POD." THE USER GUIDE ADVISES "THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4 TO 6 TIMES A DAY." IT INSTRUCTS THAT USERS TREAT DKA AS FOLLOWS: AFTER BEGINNING TREATMENT FOR HIGH BG, CHECK FOR KETONES. IF KETONES ARE PRESENT, AND ARE FEELING ILL THEN CONTACT AN HCP FOR GUIDANCE. IF KETONES ARE TRACE OR NEGATIVE THEN CONTINUE TREATING FOR HIGH BG. IF KETONES ARE POSITIVE, BUT ARE NOT FEELING ILL THEN REPLACE THE POD USING A NEW VIAL OF INSULIN. CHECK BGS AGAIN IN 2 HOURS, IF THEY HAVE NOT DECREASED THEN CONTACT AN HCP IMMEDIATELY FOR GUIDANCE. THE OMNIPOD'S USER GUIDE WARNS, "IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH." PRODUCT LOT QUALIFICATION RECORDS WERE REVIEWED AND FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    USER ACTIVATED A POD AT 11 AM. LESS THAN 1 HOUR LATER, HIS BG WAS 293 MG/DL AND KETONES STARTED TO CLIMB (NO SPECIFIC VALUES GIVEN). THEIR HCP OFFICE ADVISED THEM TO PUT ON A NEW POD. HE CONTINUED WEARING THE SAME POD AND BOLUSED 2.35 UNIT. AT 12:21 PM, HIS BG WAS 274 MG/DL. HE WENT TO THE HOSPITAL. AT 1:15 PM, HIS BG WAS 338 MG/DL AND HE DRANK A (B)(6). THE HOSPITAL ADVISED THE MOM TO ADMINISTER 2.5 UNITS OF INSULIN. AT ABOUT 2:10 PM, 5 UNITS OF INSULIN WAS GIVEN. HIS BGS STAYED IN THE 300 MG/DL RANGE FOR THE NEXT 3 HOURS. AT 4 PM HE WAS TREATED WITH 2 BAGS OF FLUIDS. BY 5 PM, HIS BG WAS 112 MG/DL. PT WENT HOME. THE POD WAS RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30872

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other