BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2902921 · Received November 29, 2012

    Report

    Report Number
    3004464228-2012-00612
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 30, 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 DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE USER'S HYPERGLYCEMIA. THE CALLER REPORTED THAT THE CANNULA DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND MAY LEAD TO HYPERGLYCEMIA. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO QUALIFICATION RECORD COULD BE REVIEWED. 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," "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 "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE ACTIVATED THE DEVICE AT 12:30 PM ON (B)(6) 2012. HER BLOOD GLUCOSE MEASURED 157 MG/DL AT 12:40 AND SHE WAS HAVING A MEAL ESTIMATED TO CONTAIN 50 GRAMS OF CARBOHYDRATE SO SHE TOOK A 4.3 UNIT INSULIN BOLUS. AT 4:20 PM SHE ADMINISTERED ANOTHER BOLUS DOSE OF 2.8 UNITS FOR AN ADDITIONAL 40 GRAMS OF CARBOHYDRATE (NO BG TEST AT THIS TIME). AT 7:00 PM HER BG MEASURED 457 MG/DL AND SHE CORRECTED WITH A 6.7 UNIT BOLUS. HER BG WAS 384 MG/DL AT 8:20 PM AND 338 MG/DL AT 9:40 PM, AT WHICH TIME AN ADDITIONAL 3.4 UNIT BOLUS WAS TAKEN. HER BG REMAINED ELEVATED, MEASURING 348 MG/DL AT 10:30 PM AND 331 MG/DL AT 11:40 (2.95 UNIT BOLUS). SHE VOMITED AROUND 11:50 PM WITH BG OF 319 MG/DL. SHE STATED THAT THE CANNULA HAD PULLED OUT OF THE SKIN. THE POD WAS DISCARDED. SHE WILL MEET WITH HER DOCTOR TO DETERMINE IF A VIRUS OR FOOD POISONING COULD HAVE CAUSED HER BLOOD GLUCOSE TO RISE.

    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 18 YR