BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3012648 · Received February 21, 2013

    Report

    Report Number
    3004464228-2013-00145
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 23, 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

    NO DEVICE WAS RETURNED FOR EVAL. WE ARE UNABLE TO ASSESS ANY PRODUCT CONDITION. THE CUSTOMER REPORTED ISSUES WITH THE CANNULA DISLODGING FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTED 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, 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," AND "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS 'HIGH CHECK FOR KETONES!' THIS INDICATED 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." NO PRODUCT LOT NUMBER WAS REPORTED, THEREFORE NO QUALIFICATION RECORDS WERE REVIEWED.

    Description of Event or Problem · 1

    THE CUSTOMER WAS NOT CALLING TO REPORT ABOUT A SPECIFIC POD PROBLEM, BUT AN ONGOING ISSUE. SHE STATED THAT OVER THE PAST THREE MONTHS, THERE HAVE BEEN MOMENTS WHEN THE CANNULA WILL COME OUT OF HER AND JUST SITS RIGHT ON TOP OF HER SKIN AND THE INSULIN "LEAKS OUT". THIS WILL CAUSE HER BLOOD GLUCOSE TO RISE, REACHING "HIGH" (>500 MG/DL) WITH LOW TO MODERATE KETONES AT TIMES. SHE ALSO REPORTED USING PROPER SITE SELECTION, SITE ROTATION, POD PLACEMENT, AND POD ACTIVATION PROCEDURES. SHE SAID THE PROBLEM NORMALLY OCCURS ABOUT A DAY AND A HALF OF WEAR, REGARDLESS OF INFUSION SITE LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76261 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR