BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3192526 · Received June 3, 2013

    Report

    Report Number
    3004464228-2013-00544
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 5, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. THE CUSTOMER REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD'S 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 SON'S BLOOD GLUCOSE RESULT WAS 446 MG/DL, WHILE WEARING A POD. SHE SAID THAT THE CANNULA HAD COME OUT OF THE SKIN, AND SHE DID NOT NOTICE THAT IT WAS KINKED UNTIL SHE REMOVED THE POD. SHE ALSO STATED THAT THE NEEDLE CAP WAS VERY DIFFICULT TO REMOVE. SHE DID NOT PROVIDE FURTHER BLOOD GLUCOSE HISTORY OR DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245303 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31073

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR