BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3170151 · Received June 6, 2013

    Report

    Report Number
    3004464228-2013-00571
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 8, 2013
    Manufacturer
    INSULET CORP
    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 NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PT'S DIABETIC KETOACIDOSIS. NO QUALIFICATION RECORDS WERE RECEIVED BECAUSE NO PRODUCT LOT NUMBER WAS PROVIDED. THE OMNIPOD USER GUIDE WARNS "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA)." 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," AND "THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY. ROUTINE CHECKS ALLOW YOU TO IDENTIFY A TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS."

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT ON (B)(6) AT 11:02 AM HER SON'S BLOOD GLUCOSE MEASURED 112 MG/DL. HE ATE ABOUT 65 GRAMS OF CARBOHYDRATE AT 11:55 AM AND 25 GRAMS AT 2:31 PM. BY 4:40 PM HIS BG READ "HIGH" (>500 MG/DL). HE HAD ANOTHER 72 GRAMS OF CARBOHYDRATE AT 5:21 PM BUT THREW UP THAT MEAL. SHE REPORTED A 13.2 UNIT INSULIN BOLUS AND A 5.10 UNIT/HOUR BASAL RATE, BUT NOT ANY TIMES ASSOCIATED WITH THESE VALUES. HE SON WAS TRANSPORTED BY AMBULANCE AND PLANE TO THE NEAREST HOSPITAL WHICH IS TWO HOURS AWAY. HE WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH BG OF 328 MG/DL. HE HAD DIABETIC KETOACIDOSIS AND WAS PLACED ON AN INSULIN DRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251974 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORP 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization