BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1944438 · Received December 28, 2010

    Report

    Report Number
    3004464228-2010-01457
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    November 27, 2010
    Report Date
    November 29, 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 POD WAS NOT RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION THAT MAY HAVE CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE OMNIPOD USER GUIDE INSTRUCTS USERS TO CHECK BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY'RE ABLE TO NOTICE AND REACT QUICKLY AND APPROPRIATELY TO HIGH BG LEVELS. THE USER GUIDE ALSO SUGGESTS THAT THE PT ALWAYS CARRY EXTRA SUPPLIES IN CASE OF AN EMERGENCY.

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT THE CUSTOMER'S BG LEVELS HAD RISEN SIGNIFICANTLY WITHIN A THREE HR PERIOD, RESULTING IN HIGH BG'S (408-412MG/DL) WITH LARGE KETONES. PRIOR TO THIS RISE IN HIS BG'S, HIS LEVELS WERE "ELEVATED"; HE WAS USING MEAL BOLUSES TO COUNTER CARBOHYDRATE INTAKE DURING THIS TIME. OVER THE THREE HR PERIOD WHERE HIS BG'S WENT HIGH, NO CARBOHYDRATES HAD BEEN INGESTED. AS A RESULT OF HIS HIGH BG LEVELS, HE VISITED THE EMERGENCY ROOM. NO INFO ABOUT HIS ER VISIT WAS PROVIDED IN THE REPORT. ADDITIONALLY, NO SPECIFIC DEVICE ISSUE WAS NOTED. THE POD WILL 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 L30385

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention