BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3251813 · Received July 18, 2013

    Report

    Report Number
    3004464228-2013-00791
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND WILL NOT RETURN FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PATIENT'S HYPERGLYCEMIA AND HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS "THE PDM WILL AUTOMATICALLY REMIND YOU TO CHECK YOUR BLOOD GLUCOSE 1.5 HOURS AFTER EACH POD CHANGE," "IF YOUR READING IS ABOVE 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 'LOW OR '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 "CHECK FOR KETONES ANY TIME YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE. IF KETONES ARE PRESENT, AND YOU ARE FEELING NAUSEATED OR ILL, IMMEDIATELY CALL YOUR HEALTHCARE PROVIDER FOR GUIDANCE."

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE ACTIVATED THE DEVICE AT 10:28 PM, ON (B)(6) 2013 AND THEN RETIRED FOR THE NIGHT WITHOUT CHECKING HER BLOOD GLUCOSE. SHE WOKE UP AT 3:57 AM, WITH A DRY MOUTH, A FRUITY TASTE IN HER MOUTH AND A FEELING OF DEHYDRATION. HER BLOOD GLUCOSE READ "HIGH" (>500 MG/DL). SHE TOOK A 6.9 UNIT BOLUS AND WENT BACK TO SLEEP. SHE WOKE UP AND VOMITED ABOUT FOUR TIMES BETWEEN THEN AND 6:00 AM. AT THIS TIME SHE WENT TO THE EMERGENCY ROOM. SHE HAD SEVERE CHEST PAINS AND BLOOD GLUCOSE OF 742 MG/DL. THE POD WAS DEACTIVATED AT 6:39 AM AND DISCARDED. WHEN IT WAS REMOVED, SHE NOTED THAT THE ADHESIVE WAS WET AND THE CANNULA HAD A SLIGHT CURVE, BUT NO BEND OR KINK. SHE WAS IN THE HOSPITAL AT THE TIME OF HER CALL, BUT HER BLOOD GLUCOSE WAS WITHIN HER 88-133 MG/DL TARGET RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335258 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40381

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization