BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3030585 · Received March 21, 2013

    Report

    Report Number
    3004464228-2013-00249
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 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 DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER DEVICE CONDITION COULD HAVE CONTRIBUTED TO THE PATIENT'S HYPERGLYCEMIA AND HOSPITAL VISIT. NO QUALIFICATION RECORDS COULD BE REVIEWED AS NO PRODUCT LOT NUMBER WAS REPORTED. THE OMNIPOD USER GUIDE WARNS "IF YOUR READING IS ABOUT 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" AND "'HIGH BLOOD' GLUCOSE READINGS CAN INDICATE A POTENTIALLY SERIOUS CONDITION REQUIRING IMMEDIATE MEDICAL ATTENTION. IF LEFT UNTREATED, THIS SITUATION CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA), SHOCK, COMA, OR DEATH." IT ADVISES "ANY TIME YOUR BLOOD GLUCOSE IS LOW, TREAT IT IMMEDIATELY. CHECK IT EVERY 15 MINUTES WHEN YOU ARE TREATING, TO MAKE SURE YOU DON'T OVER-TREAT THE CONDITION AND CAUSE BLOOD GLUCOSE LEVELS TO RISE TOO HIGH."

    Description of Event or Problem · 1

    THE PATIENT REPORTED LOW BLOOD GLUCOSE ON THE EVENING OF (B)(6), WHICH SHE TREATED BY SNACKING (2 ORANGES, A SMALL BAG OF CHIPS, AND SOME FROSTING). SHE DID NOT TEST BG AGAIN UNTIL THE NEXT MORNING, WHEN HER BG READ "HIGH" (>500 MG/DL) AT 10:15 AM, WHICH SHE CORRECTED WITH A 3 UNIT BOLUS. TEN MINUTES LATER, SHE GOT THE SAME RESULT AND GAVE THE SAME TREATMENT. BY 10:47 AM HER BG WAS DOWN TO 322 MG/DL WHICH SHE CORRECTED WITH A 4.3 UNIT BOLUS. WHILE AT THE DERMATOLOGIST (NO TIME REPORTED) SHE BEGAN VOMITING AND PARAMEDICS WERE CALLED. HE BG READ "HIGH" (>600 MG/DL) ON THEIR METER, BUT THEY DID NOT TREAT HER. SHE GAVE HERSELF 7 UNITS OF INSULIN BY INJECTION, BUT HER BG DID NOT IMPROVE, SO HER HUSBAND DROVE HER TO THE HOSPITAL. SHE WAS TREATED IN THE EMERGENCY ROOM WITH IV FLUIDS, INSULIN AND ANTI-NAUSEA MEDICATION. THE POD WAS DEACTIVATED BY 11:37 AM AND WAS REMOVED AND DISCARDED AT THE HOSPITAL. AT THE TIME OF HER CALL HER BG WAS 180 MG/DL, SHE WAS FEELING BETTER AND EXPECTED TO GO THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117636 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization