BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2151615 · Received June 29, 2011

    Report

    Report Number
    3004464228-2011-00315
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    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 POD WILL NOT BE RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM ANY DEVICE MALFUNCTION THAT MAY HAVE RESULTED IN THE OVER-DELIVERY OF INSULIN, CAUSING LOW BG LEVELS. NO SPECIFIC FAILURE MODE WAS CITED IN THE REPORT. BASED SOLELY ON THE INFO PROVIDED IN THE REPORT, WE ARE UNABLE TO CONCLUDE THAT THE POD WAS, OR MAY HAVE BEEN, A CONTRIBUTING FACTOR TO THE HYPOGLYCEMIC EVENT EXPERIENCED BY THE CUSTOMER, RESULTING IN THE VISIT TO THE EMERGENCY ROOM. NO CONCLUSION CAN BE DRAWN. BUILT INTO THE POD'S DESIGN ARE ELECTRICAL, MECHANICAL AND SOFTWARE SAFETY FEATURES THAT PREVENT THE DEVICE FROM OVER-DELIVERING INSULIN (WHICH COULD RESULT IN LOW BG LEVELS). THE CUSTOMER DOES NOT USE THE BOLUS CALCULATOR FEATURE OF THE SYSTEM - SHE "MANUALLY CALCULATES HER RADIOS AND TELLS THE PDM HOW MUCH TO DELIVER." THE HISTORY OF BOLUS DOSAGES ADMINISTERED PRIOR TO THE EVENT WAS NOT PROVIDED. IT, THEREFORE, CANNOT BE DETERMINED WHETHER THE CUSTOMER MAY HAVE ADMINISTERED AN EXCESS DOSAGE OF INSULIN, WHICH COULD HAVE RESULTED IN THE LOW BG LEVELS. THE LOT NUMBER OF THE SUBJECT POD WAS NOT PROVIDED - A REVIEW OF LOT QUALIFICATION RECORDS, THEREFORE, COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER "IS NEW TO THE POD AND IS STILL LEARNING." SHE HAD EXPERIENCED LOW BG LEVELS WITH THIS POD AND "CHECKED INTO THE HOSPITAL" AS A RESULT. WITHIN THREE HOURS OF ACTIVATING THE DEVICE, HER BG LEVEL MEASURE 53 MG/DL, TWENTY-FOUR HOURS AFTER ACTIVATING THE POD, HER LEVELS CONTINUED TO BE LOW (39-68 MG/DL). AFTER CHECKING IN TO THE ER, THE "DOCTOR ASKED TO HAVE ALL INSULIN DELIVERY STOPPED." THE CUSTOMER WAS ASLEEP AT THE TIME THE NURSE HAD CALLED IN THIS REPORT; THE NURSE, THEREFORE, WAS "UNABLE TO PROVIDE INFO ON THE POD AND SITE." THE NURSE WAS GOING TO USE THE PDM TO ENSURE THE POD WAS DEACTIVATED AND WILL HAVE THE DEVICE REMOVED. THE POD WILL NOT BE RETURNED FOR INVESTIGATION. NOTE: THE REPORT INDICATED THAT THE CUSTOMER'S BG LEVELS HAD SUCCESSFULLY RISEN BY THE AFTERNOON INTO THE EVENING HOURS (UP TO 198 AND 185 MG/DL, RESPECTIVELY).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization