BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2870428 · Received November 13, 2012

    Report

    Report Number
    3004464228-2012-00583
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    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 DEVICES WERE DISCARDED AND WILL NOT BE RETURNED FOR EVAL. WE CANNOT ASSESS THE PRODUCT CONDITION OR DETERMINE IF ANY MALFUNCTION OR DEFECT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. THE CALLER REPORTED THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION WOULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HIGH BLOOD GLUCOSE. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO QUALIFICATION RECORD REVIEW COULD BE PERFORMED. THE OMNIPOD USER¿S 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 CAREGIVER REPORTED THAT CUSTOMER HAD 3 PODS OVER THE PAST 3 WEEKS THAT THE CANNULA HAD COME OUT AND THE CUSTOMERS BLOOD GLUCOSE WENT UP TO OVER 500 MG/DL. THE CUSTOMER¿S BG DID NOT COME DOWN WITH BOLUSES. THE DEVICES WERE DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR