BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3001335 · Received March 6, 2013

    Report

    Report Number
    3004464228-2013-00189
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 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 RETURNED DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED. NO MALFUNCTION, DEFECT OR OTHER PRODUCT CONDITION THAT WOULD RESTRICT OR INTERRUPT INSULIN DELIVERY AND CONTRIBUTED TO REPORTED HYPERGLYCEMIA AND HIGH KETONES WAS FOUND. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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, 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 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 PT'S MOTHER REPORTED THE FOLLOWING BLOOD GLUCOSE AND INSULIN HISTORY FOR HER DAUGHTER FROM (B)(6) 2013. AT 10:50 AM ON 3/4 THEY WENT TO THE EMERGENCY ROOM WHERE HE TESTED AT THE HIGHEST LEVEL FOR KETONES. AT 11:00 AM HER BG WAS DOWN TO 181 MG/DL AND ANOTHER 0.9 UNITS WERE GIVEN. THE HOSPITAL TOLD THE PT AND HER MOTHER THAT "THE POD IS THE CAUSE OF THE HIGH BG." THE KETONES WERE NEGATIVE WHEN THEY LEFT THE ER. THE CALLER DID NOT DESCRIBE ANY TREATMENT RECEIVED AT THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95224 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30968

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other