BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSUILN PUMP

    MDR report key: 2042271 · Received March 29, 2011

    Report

    Report Number
    3004464228-2011-00123
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 28, 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 EVAL. WE ARE UNABLE TO CONFIRM ANY DEVICE MALFUNCTION THAT MAY HAVE PREVENTED OR RESTRICTED INSULIN FLOW, RENDERING BOLUS ATTEMPTS INEFFECTIVE. NO SPECIFIC FAILURE MODE WAS NOTED IN THE REPORT. BASED ON THE INFO PROVIDED AND IN THE ABSENCE OF A DEVICE EVAL, WE CANNOT CONFIRM THAT A POD MALFUNCTION WAS A CONTRIBUTING FACTOR TO THE CUSTOMER'S HIGH BG LEVELS. NO CONCLUSION CAN BE DRAWN. THE OMNIPOD USER GUIDE INSTRUCTS THE CONSUMER 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. THE CUSTOMER'S BG HISTORY SHOWS THAT THE DEVICE HAD BEEN WORN FOR 23 HOURS AFTER THE FIRST BOLUS WAS ADMINISTERED BEFORE BEING DEACTIVATED. 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 REPORT INDICATED THAT THE CUSTOMER WAS ADMITTED TO THE HOSPITAL "DUE TO HIGH BG'S." A REVIEW OF HIS BG HISTORY SHOWS THAT HIS LEVELS WERE HIGH (404MG/DL) THE MORNING AFTER THE POD WAS PLACED; A CORRECTION BOLUS WAS IMMEDIATELY ADMINISTERED, BUT HIS LEVELS CONTINUED TO RISE OVER THE NEXT THREE HOURS (UP TO 481MG/DL). THROUGHOUT THE FOLLOWING 24-HOURS PERIOD, MULTIPLE CORRECTION BOLUSES HAD BEEN ADMINISTERED, BUT HIS BG LEVELS WERE CONSISTENTLY GREATER THAN 500MG/DL. AS A RESULT, HE WAS TAKEN TO THE HOSPITAL. (HIS BG LEVEL REPORTEDLY REACHED 1,565MG/DL - THIS READING WAS PRESUMABLY TAKEN WITH THE HOSPITAL'S METER.) THE POD WAS DISCARDED AT THE HOSPITAL AND WILL THEREFORE NOT BE RETURNING FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization