BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1944435 · Received December 28, 2010

    Report

    Report Number
    3004464228-2010-01452
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    November 28, 2010
    Report Date
    November 28, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PDM WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY MALFUNCTION OF THE DEVICE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE PROGRAMMING OF UNINTENDED BOLUS DELIVERIES. ADDITIONALLY, WE ARE UNABLE TO REVIEW THE DEVICE'S HISTORY LOGS TO IDENTIFY ANY SUSPECT BOLUS DELIVERIES (THAT MAY HAVE BEEN ADMINISTERED WHILE THE CUSTOMER WAS SLEEPING). WITHOUT THE PDM RETURNED FOR INVESTIGATION, NO CONCLUSION CAN BE DRAWN. NOTE: THE POD ASSOCIATED WITH THIS EVENT WAS EXPECTED TO HAVE BEEN RETURNED FOR EVALUATION., BUT HAS NOT BEEN RECEIVED TO DATE. WITHOUT THE DEVICE RETURNED FOR INVESTIGATION, NO MALFUNCTION CAN BE CONFIRMED THAT MAY HAVE RESULTED IN AN OVER-DELIVERY OF INSULIN, WHICH WOULD HAVE CONTRIBUTED TO THE CUSTOMER'S LOW BG LEVELS. BUILT INTO THE POD'S DESIGN ARE ELECTRICAL, MECHANICAL AND SOFTWARE SAFETY FEATURES THAT PREVENT THE DEVICE FROM OVER-DELIVERING INSULIN. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE POD IS RETURNED FOR EVALUATION AFTER THIS DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE BELIEVES THE PDM MAY HAVE PROGRAMMED THE POD TO ADMINISTER UNINTENDED BOLUSES WHILE SHE WAS SLEEPING, WHICH LEAD TO A DIABETIC SEIZURE. FIFTEEN MINUTES AFTER THE SEIZURE BEGAN, SHE ATTEMPTED TO USE THE PDM TO MANAGE HER CONDITION; THE PDM INITIATED MULTIPLE METER ERRORS OVER THE FOLLOWING FIFTEEN MINUTES. SHE EVENTUALLY RECEIVED A GLUCAGON SHOT AND "RECOVERED" A HALF-HOUR AFTER THE EPISODE BEGAN. SHE TESTED HER BGS WITH A BACK-UP METER AN HOUR AFTER THE EVENT - HER LEVEL AT THAT TIME WAS 100MG/DL. HER INSULIN DELIVERY HISTORY SHOWS TWO BOLUSES BEING ADMINISTERED: THERE WAS NO TIME STAMP ASSOCIATED WITH THE FIRST BOLUS; THE SECOND BOLUS WAS ADMINISTERED BEFORE SHE HAD GONE TO BED. THE PDM WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 13100-2B L50010

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other