BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3173006 · Received May 30, 2013

    Report

    Report Number
    3004464228-2013-00532
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 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 RETURNED DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED. THE POD WAS FOUND TO HAVE TERMINATED IN A HAZARD ALARM, A SAFETY FEATURE NOT CONSIDERED A MALFUNCTION. INSPECTION OF THE INSERTION MECHANISM AND FOUND NO DEFECTS THAT WOULD CAUSE A LATE/NO INSERTION. THE CALLER REPORTED THAT THE CANNULA WAS VISIBLE OUTSIDE THE SKIN AND HAD NOT INSERTED PROPERLY. THIS COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. IT CANNOT BE CONFIRMED, NOR EXCLUDED, THROUGH LABORATORY TESTING. THE OMNIPOD USER GUIDE WARNS "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IT IS ALSO A GOOD IDEA TO CHECK YOUR BLOOD GLUCOSE ABOUT TWO HOURS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT, "WHEN A HAZARD ALARM OCCURS IN THE POD, ALL INSULIN DELIVERY STOPS. FAILING TO ADDRESS THE SITUATION COULD RESULT IN HYPERGLYCEMIA," AND "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." IT CAUTIONS "DUE TO THE SERIOUS NATURE OF HAZARD ALARMS, YOU MUST ACT PROMPTLY TO RESOLVE THEM. ACKNOWLEDGE THE ALARM CONDITION BY PRESSING OK, WHICH SILENCES THE ALARM. DEACTIVATE AND REMOVE THE ACTIVE POD AND ACTIVATE AND APPLY A NEW POD." QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT THE POD WAS ACTIVATED AT ABOUT 7:00 PM, WHICH TIME HER DAUGHTER'S BLOOD GLUCOSE WAS IN RANGE. HER DAUGHTER WENT TO BED AT ABOUT 8:00 PM AND AT 6:00 AM THE NEXT MORNING HER BG WAS 421 MG/DL WITH LARGE KETONES. THE MOTHER CHECKED THE DEVICE AND COULD SEE THAT THE CANNULA WAS LYING ON THE SKIN RATHER THAN INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238700 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31074

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR