BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3232039 · Received July 5, 2013

    Report

    Report Number
    3004464228-2013-00710
    Event Type
    Injury
    Date Received
    July 5, 2013
    Date of Event
    May 11, 2013
    Report Date
    June 5, 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 RETURNED DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED DURING TESTING. NO DEFECT OR DEFICIENCY THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS FOUND. THE ADHESIVE PAD WAS FULLY ADHERED WHEN RETURNED. THE ORIGINAL ADHESIVE PROPERTIES COULD NOT BE DETERMINED. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS, "CHECK OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY ATTACHED AND IN PLACE. A LOOSE OR DISLODGED CANNULA MAY INTERRUPT INSULIN DELIVERY" AND "BECAUSE INSULIN PODS USE ONLY RAPID-ACTING INSULIN, USERS ARE AT INCREASED RISK FOR DEVELOPING HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) IF INSULIN DELIVERY IS INTERRUPTED. IF IT IS UNTREATED, SEVERE HYPERGLYCEMIA CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA). DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, OR DEATH. IF INSULIN DELIVERY IS INTERRUPTED FOR ANY REASON, YOU MAY NEED TO REPLACE THE MISSING INSULIN - USUALLY WITH AN INJECTION OF RAPID-ACTING INSULIN. ASK YOUR HEALTHCARE PROVIDER FOR INSTRUCTIONS ON HANDLING INTERRUPTED INSULIN DELIVERY." IT ALSO WARNS, "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS '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. IF YOU GET A 'HIGH CHECK FOR KETONES!' READING, PERFORM A CONTROL SOLUTION TEST TO ENSURE YOUR SYSTEM IS WORKING PROPERLY. IF THE SYSTEM IS WORKING PROPERLY, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPERGLYCEMIA." IT ADVISES, "TO AVOID HYPERGLYCEMIA (HIGH BLOOD GLUCOSE): CHECK YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY (WHEN YOU WAKE UP, BEFORE EACH MEAL, AND BEFORE GOING TO BED)."

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER DAUGHTER'S BLOOD GLUCOSE RESULTS WERE "HIGH" (>5000 MG/DL) AND THE POD HAD FALLEN OFF WHILE ON THE SITE. SHE BROUGHT HER DAUGHTER TO THE HOSPITAL BECAUSE SHE WANTED TO ENSURE THAT EVERYTHING WAS OKAY. AT THE HOSPITAL, HER RESULT WAS 517 MG/DL AND SHE WAS NEGATIVE FOR KETONES. THE POD WAS REPLACED AND SHE WAS GIVEN INSULIN AT THE HOSPITAL. HER BLOOD GLUCOSE RESULTS WERE BACK TO NORMAL IN A COUPLE OF HOURS. SHE PROVIDED THE FOLLOWING RESULTS: TIME: 10:34 AM, BG RESULT (MG/DL): 343; 3:22 PM, 243; 5:50 PM, 167.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307370 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31040

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other