BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3030615 · Received March 22, 2013

    Report

    Report Number
    3004464228-2013-00253
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 23, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS A PRODUCT LOT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER" 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, "IF YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE, CHECK FOR KETONES. IF KETONES ARE PRESENT, FOLLOW YOUR HEALTHCARE PROVIDER'S GUIDELINES. IF KETONES ARE NOT PRESENT, TAKE A CORRECTION BOLUS AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER. CHECK BLOOD GLUCOSE AGAIN AFTER 2 HOURS. IF BLOOD GLUCOSE LEVELS HAVE NOT DECREASED, TAKE A SECOND BOLUS BY INJECTION, USING A STERILE SYRINGE. IF YOU FEEL NAUSEATED AT ANY POINT, CHECK FOR KETONES AND CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY. IF BLOOD GLUCOSE REMAINS HIGH AFTER ANOTHER 2 HOURS (A TOTAL OF 4 HOURS), REPLACE THE POD."

    Description of Event or Problem · 1

    THE PATIENT'S POD WAS ACTIVATED ON (B)(6) AT 10:08PM. HE BLOOD GLUCOSE WAS NORMAL UNTIL (B)(6) AT 10:35PM, WHEN IT WAS 428 MG/DL. AFTER A 6.55U BOLUS, IT DECREASED AND SHE HAD NORMAL RESULTS UNTIL (B)(6) AT 9:00AM, WHEN IT WAS 319 MG/DL. SHE TOOK A 4.35U BOLUS AND HAD A RESULT OF 147 MG/DL AT 11:15AM. AT 6:10PM, IT HAD RISEN TO 475 MG/DL, AND SHE TOOK A 10.3U BOLUS. HER RESULTS WERE NORMAL UNTIL 12:31PM ON (B)(6), WHEN IT WAS 392 MG/DL. SHE TOOK A 5.8 UNIT BOLUS. THE FOLLOWING HISTORY WAS REPORTED FOR THE REST OF (B)(6). AT 10:21PM, IT WAS 402 MG/DL, AND SHE WAS TAKEN TO THE HOSPITAL BECAUSE SHE WAS GOING INTO DIABETIC KETOACIDOSIS. SHE WAS TRANSPORTED TO THE ICU OF A (B)(6) HOSPITAL. THE POD WAS REMOVED AND DISPOSED OF WHEN SHE ARRIVED AT 11:00PM, SHE WAS GIVEN AN INTRAVENOUS DRIP FOR 20 HOURS, AS WELL AS FLUIDS AND POTASSIUM, AND WAS HOSPITALIZED FOR 20-24 HOURS. THE HOSPITAL DID NOT KNOW IF THE CANNULA WAS KINKED, OR IF THE HYPERGLYCEMIA WAS BECAUSE OF A STOMACH VIRUS OR HORMONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119782 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization