BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2221269 · Received August 17, 2011

    Report

    Report Number
    3004464228-2011-00401
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 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 WILL NOT BE RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS, LEADING TO DKA AND A HOSPITAL VISIT. NO SPECIFIC FAILURE MODE WAS NOTED IN THE REPORT. BASED ON THE INFO PROVIDED AND IN THE ABSENCE OF A DEVICE EVAL, WE CANNOT CONCLUDE THAT A POD MALFUNCTION WAS A CONTRIBUTING FACTOR TO THE EVENT. NO CONCLUSION CAN BE DRAWN. A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED. THE LOT PASSED THE ACCEPTANCE CRITERIA. NOTE: EVAL METHOD CODES ARE SPECIFIC TO ACTIVITIES PERFORMED DURING LOT QUALIFICATION, AND NOT TO ACTIVITIES PERFORMED ON THE SUBJECT POD (AS IT WAS NOT RETURNED FOR EVAL).

    Description of Event or Problem · 1

    THE POD'S ALL HISTORY SHOWS THAT THE CUSTOMER BEGAN EXPERIENCING HIGH BG LEVEL (368MG/DL) LATE AT NIGHT THAT PERSISTED THROUGH TO THE NEXT MORNING. HER BG LEVEL BY EARLY MORNING WAS 419MG/DL; A CORRECTION BOLUS WAS IMMEDIATELY ADMINISTERED, BUT HER LEVELS CONTINUED TO CLIMB FOUR HOURS LATER (TO GREATER THAN 500MG/DL). SHE WAS TAKEN TO THE HOSPITAL LATER IN THE MORNING WITH DKA, WHERE SHE WAS "PUT ON IV INSULIN." THE CUSTOMER'S HUSBAND HAD CALLED FROM THE HOSPITAL, BUT DUE TO "TERRIBLE" PHONE RECEPTION, LIMITED INFO WAS ABLE TO BE GATHERED. NO SPECIFIC FAILURE MODE OF THE POD WAS NOTED IN THE REPORT. THE SUSPECT DEVICE WAS DEACTIVATED AT THE HOSPITAL, BUT WILL NOT BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30257

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention