BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2962043 · Received January 23, 2013

    Report

    Report Number
    3004464228-2013-00059
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 24, 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 PRODUCT WAS NOT RETURNED FOR EVAL. THE USER REPORTED CANNULA LOOKS BENT. WE ARE UNABLE TO CONFIRM THE REPORTED CONDITION OR DETERMINE WHETHER IT 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, 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. USE A NEW VIAL OF INSULIN TO FILL THE NEW POD".

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE ACTIVATED THE DEVICE ON (B)(6) 2012 IN THE MORNING, THE NEXT AT 11:16 AM, HER BLOOD GLUCOSE WAS 321 MG/DL. SHE CORRECTED WITH A 2.85 UNIT INSULIN BOLUS. AT 12:37 PM, GER BG REMAINED HIGH, MEASURING 270 MG/DL; ANOTHER 1.35 UNITS WERE BOLUSED. AT 2:17 PM, WITH BG OF 186 MG/DL, SHE TOOK AN INSULIN BOLUS OF 1.95 UNITS AND ANOTHER OF 0.6 UNITS AT 3:30 PM (NO BG RESULT). AT 5:23 PM, HER BG WAS BACK UP TO 258 MG/DL; SHE CORRECTED WITH A 1.5 UNIT BOLUS AT 6:00 PM. BY 8:49 PM, HER BG WAS 434 MG/DL AND SHE ADMINISTERED A 7.85 UNIT CORRECTION BOLUS, BUT AT 10:03, HER BG WAS STILL 410 MG/DL. SHE DEACTIVATED THE DEVICE AND OBSERVED THAT THE CANNULA WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33008 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30935

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR