BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2233971 · Received August 31, 2011

    Report

    Report Number
    3004464228-2011-00549
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    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 POD WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS AND KETOACIDOSIS. NO SPECIFIC FAILURE MODE WAS CITED IN THE REPORT. THE CUSTOMER SUSPECTED THAT "THE PUMP WAS NOT DELIVERING INSULIN". HOWEVER, THIS CANNOT BE CONFIRMED BASED SOLELY ON THE INFORMATION PROVIDED IN THE REPORT AND IN THE ABSENCE OF AN INVESTIGATION. NO CONCLUSION CAN BE DRAWN. THE OMNIPOD USER GUIDE INSTRUCTS THE CUSTOMER TO "REPLACE THE POD" AND "CONTACT YOUR HEALTHCARE PROVIDER FOR GUIDANCE" IF BLOOD GLUCOSE LEVELS REMAIN HIGH FOR A TOTAL OF FOUR HOURS AFTER A CORRECTION BOLUS WAS FIRST ADMINISTERED. NO POD LOT NUMBER WAS PROVIDED. A REVIEW OF LOT QUALIFICATION RECORDS WAS THEREFORE UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER WAS EXPERIENCING HIGH BG LEVELS IN THE MORNING HOURS (296-313MG/DL) DESPITE HAVING ADMINISTERED CORRECTION BOLUSES. SHE THEREFORE FELT THAT "THE PUMP WAS NOT DELIVERING INSULIN." THE POD WAS DEACTIVATED AND SHE WENT TO THE HOSPITAL WHERE SHE WAS ADMITTED WITH KETOACIDOSIS AND A BG LEVEL OF 460MG/DL. SHE WAS PLACED ON INSULIN DRIP (BUT DOESN'T REMEMBER HOW MUCH OR FOR HOW LONG). THE POD WAS THROWN AWAY AND WILL THEREFORE NOT 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 11200 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization