BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3172785 · Received May 31, 2013

    Report

    Report Number
    3004464228-2013-00540
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 4, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    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 CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. 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 "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS "HIGH CHECK FOR KETONES!" THIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). IF YOU GET A '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." 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 REMOVED THE POD WHEN HE NOTICED IT HAD STARTED TO COME AWAY FROM HIS SKIN. AFTER IT WAS REMOVED, HE ALSO OBSERVED THAT THE CANNULA WAS BENT. THIRTY MINUTES LATER HIS BLOOD GLUCOSE READ "HIGH" (>500 MG/DL). THE DEVICE WAS IN USE LESS THAN A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241480 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31106

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR