BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3030613 · Received March 22, 2013

    Report

    Report Number
    3004464228-2013-00257
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 22, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT DEFECT CONTRIBUTED TO THE PATIENT'S EMERGENCY ROOM VISIT. THE CALLER REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. 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." NO QUALIFICATION RECORD REVIEW WAS PERFORMED AS NO PRODUCT LOT NUMBER WAS REPORTED.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT MOM CALLED IN STATED A COUPLE OF WEEKS AGO HER DAUGHTER HAD TO GO THE EMERGENCY ROOM WITH KETONES AND HYPERGLYCEMIA (APPROXIMATELY 400 MG/DL) SHE STATED THAT THE CANNULA HAD COME OUT OF THE SKIN AND SHE HAD NOT NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119079 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other