BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3030735 · Received March 26, 2013

    Report

    Report Number
    3004464228-2013-00259
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    October 24, 2012
    Report Date
    February 25, 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 NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA, DIABETIC KETOACIDOSIS AND HOSPITALIZATION. THE CUSTOMER REPORTED THAT THE CANNULA DISLODGED FROM THE INSULIN SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS A PRODUCT LOT NUMBER WAS NOT PROVIDED. 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 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 WAS OVER 600 MG/DL, AND SHE WENT INTO DIABETIC KETOACIDOSIS AND THYROID STORM. SHE ALSO HAS GRAVES' DISEASE. THE MOTHER DID NOT REALIZE THAT THE CANNULA HAD DISLODGED AND WAS NOT DELIVERING INSULIN. HER DAUGHTER WAS SENT TO A CHILDREN'S HOSPITAL, WHERE SHE WAS TREATED WITH AN INSULIN DRIP, AND SLOWLY BEGAN USING MANUAL INJECTIONS. HER DOCTOR ASKED THEM TO DISCONTINUE USING THE PODS BECAUSE THE HOSPITAL STAFF DID NOT KNOW HOW TO USE THEM, SO SHE WAS USING THE PDM FOR THE BLOOD GLUCOSE METER ONLY. SHE WAS HOSPITALIZED FOR 4 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124219 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization