BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2843703 · Received October 26, 2012

    Report

    Report Number
    3004464228-2012-00535
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 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 WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE KINKED CONDITION OF THE CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER'S 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 GUIDELINE," AND ADVISES "IF YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE, CHECK FOR KETONES. 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 BLOOD GLUCOSE REMAINS HIGH AFTER ANOTHER 2 HOURS (A TOTAL OF 4 HOURS), REPLACE THE POD."

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER SON ACTIVATED THE SUBJECT DEVICE ON (B)(6) 2012 AT 3:17 PM. HIS BLOOD GLUCOSE AT THAT TIME MEASURED 442 MG/DL, BUT WAS REDUCED TO 203 MG/DL BY 4:30 PM. IT ROSE AGAIN IN THE EARLY MORNING HOURS OF (B)(6) 2012 (320 MG/DL AT 3:29 AM), BUT WAS DOWN TO 156 MG/DL AT 6:45 AM. HIS BG MEASURED 261 MG/DL AT 11:05 AM AND 270 MG/DL AT 9:12 PM. NO INSULIN DOSES OR CARBOHYDRATE INTAKE WERE REPORTED. BY THE MORNING OF (B)(6), HIS BG WAS NORMAL AGAIN (148 MG/DL AT 3:19 AM AND 105 MG/DL AT 6:51 PM), BUT CLIMBED AGAIN BY AFTERNOON, MEASURING 394 MG/DL AT 12:05 PM AND 385 MG/DL AT 1:00 PM. AT THIS TIME, THE DEVICE WAS DEACTIVATED AND THE CALLER OBSERVED THAT THE CANNULA WAS KINKED "A LITTLE BIT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30825

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR