BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2041960 · Received March 29, 2011

    Report

    Report Number
    3004464228-2011-00121
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 23, 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 THROUGHLY EVALUATED AND NO EVIDENCE OF ANY DAMAGE OR MANUFACTURING DEFICIENCY WAS FOUND THAT WOULD HAVE DIRECTLY CAUSED OR CONTRIBUTED TO EITHER INSUFFICIENT OR NO INSULIN DELIVERY. FLUID EXITED THE TIP OF THE CANNULA WHEN THE DRIVE MECHANISM WAS ACTUATED. NO PROBLEM WAS FOUND IN THE RETURNED DEVICE. AN AIR BUBBLE, HOWEVER, WAS FOUND WITHIN THE POD'S INSULIN RESERVOIR - THIS TYPICALLY OCCURS WHEN AIR IS INTRODUCED INTO THE POD DURING THE FILL PROCESS AND IS NOT RELATED TO ANY MANUFACTURING PROCESS ISSUE OR PRODUCT DEFECT. THE OMNIPOD USER'S GUIDE INSTRUCTS USERS ON PROPER FILLING TECHNIQUE TO AVOID THIS CONDITION, AS FAILURE TO DO SO MAY RESULT IN UNINTENDED/INTERRUPTED INSULIN DELIVERY. "USER ERROR", THEREFORE, IS CONSIDERED TO BE A CONTRIBUTING FACTOR TO THE CUSTOMER'S REPORTED HIGH BGS. THE USER IS INSTRUCTED IN THE USER GUIDE TO PERIODICALLY CHECK THE INFUSION SITE AND TO FREQUENTLY MONITOR THEIR BG LEVELS. BY FOLLOWING THESE RECOMMENDATIONS, THE USER WOULD BECOME AWARE OF HIGH BG LEVELS AND COULD USE ANOTHER DEVICE OR BACKUP THERAPY IF REQUIRED. INSULET HAS INITIATED AN INTERNAL INVESTIGATION TO IDENTIFY THE ROOT CAUSE OF THIS FAILURE MODE. THE INVESTIGATION IS IN-PROCESS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT PATIENT HAD HIGH BGS (BG METER READ "HIGH") AFTER WEARING THE POD FOR A DAY. CUSTOMER WAS ABLE TO LOWER BGS TO 210MG/DL OVER THE NEXT 7 HOURS BEFORE DEACTIVATING THE POD. POD 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 11200 L30414

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other