BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2983266 · Received February 1, 2013

    Report

    Report Number
    3004464228-2013-00085
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    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 THE KINKED AND BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO REPORTED HYPERGLYCEMIA. 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 BLOOD GLUCOSE REMAINS HIGH AFTER ANOTHER 2 HOURS (A TOTAL OF 4 HOURS), REPLACE THE POD."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POD WAS ACTIVATED ON (B)(6) 2013 AT 6:54 PM. HIS BLOOD GLUCOSE MEASURED 133 MG/DL AT 9:55 PM. ON (B)(6), HIS BG MEASURED 267 MG/DL AT 12:59 AM AND 314 MG/DL AT 4.45 AM; A 0.95 UNIT CORRECTION BOLUS WAS GIVEN AT A LATER TIME. HIS BG WAS 301 MG/DL AT 6:45 AM AND ANOTHER 0.80 UNITS WAS BOLUSED TO CORRECT. HIS BG WAS 311 MG/DL AT 8:21 AM AND 395 AT 9:27 AM. HE DEACTIVATED THE DEVICE AT 9:30 AM AND THE CANNULA WAS KINKED AND BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45206 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30942

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR