BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2953865 · Received February 1, 2013

    Report

    Report Number
    3004464228-2013-00077
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 2, 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 WILL NOT RETURN FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPOGLYCEMIA, COMA, AND HOSPITALIZATION. THERE ARE SAFETY MECHANISMS IN THE DESIGN OF THE POD TO PREVENT THE OVER-DELIVERY OF INSULIN THAT CONTRIBUTES TO HYPOGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS "TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER," AND "EVEN IF YOU CANNOT CHECK YOUR BLOOD GLUCOSE, DO NOT WAIT TO TREAT SYMPTOMS OF HYPOGLYCEMIA, ESPECIALLY IF YOU ARE ALONE. WAITING TO TREAT SYMPTOMS COULD LEAD TO SEVERE HYPOGLYCEMIA, WHICH CAN QUICKLY LEAD TO SHOCK, COMA, OR DEATH." IT ADVISES "ALWAYS CHECK YOUR BLOOD GLUCOSE LEVELS FREQUENTLY WHILE TREATING HYPERGLYCEMIA. YOU DON'T WANT TO OVER-TREAT THE CONDITION AND CAUSE YOUR BG LEVEL TO DROP TOO FAR."

    Description of Event or Problem · 1

    THE PATIENT'S WIFE REPORTED THAT HER HUSBAND PLACED THE POD ON HIS UPPER LEFT SHOULDER AND ACTIVATED IT ON THE EVENING OF (B)(6) 2012. SHE RELATED THE FOLLOWING HISTORY FROM HER HUSBAND'S PDM. AT 4:00 AM ON (B)(6), HIS BLOOD GLUCOSE MEASURED 254 MG/DL AND HE ENTERED 225 GRAMS OF CARBOHYDRATE, WHICH RESULTED IN A SUGGESTED BOLUS OF 22.85 UNITS. 21.65 UNITS WERE DELIVERED BEFORE THE POD ALARMED AT 4:15 AM AND WAS DEACTIVATED AT 4:17 AM. HE ACTIVATED A NEW DEVICE AT 4:28 AM WITH BASAL INSULIN SET AT 2.00 UNITS/HOUR. HIS BG AT 4:32 AM WAS STILL 254 MG/DL. HE ENTERED 202 GRAMS OF CARBOHYDRATE, WHICH RESULTED IN A SUGGESTED BOLUS OF 17.25 UNITS DELIVERED STARTING AT 4:32 AM. SHE STATED THAT WHEN SHE TRIED TO WAKE HIM ON THE MORNING OF (B)(6), HE WOULD NOT WAKE UP, AND WAS SWEATING. SHE CALLED 911. THE EMTS MEASURED HIS BG AND IT WAS 30 MG/DL. HE WAS UNRESPONSIVE AND WAS RUSHED TO THE ER. HIS BG WAS 57 WHEN HE ARRIVED AT HOSPITAL. HE WAS IN A DIABETIC COMA FOR 10 DAYS AND GOT OUT OF THE HOSPITAL ON (B)(6) 2012. HE CURRENTLY NEEDS REHABILITATION, PHYSICAL THERAPY AND IN-HOME NURSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43744 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30924

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization