BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2112366 · Received May 25, 2011

    Report

    Report Number
    3004464228-2011-00227
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 26, 2011
    Manufacturer
    INSULET CORP
    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 THOROUGHLY EVALUATED AND NO EVIDENCE OF ANY MALFUNCTION OR MFG DEFICIENCY WAS FOUND THAT WOULD HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. 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 MFG PROCESS ISSUE OR PRODUCT DEFECT. THE OMNIPOD USER'S GUIDE INSTRUCTS USERS ON PROPER FILLING TECHNIQUE AND INCLUDES THE FOLLOWING WARNING: "NEVER INJECT AIR INTO THE FILL PORT. DOING SO MAY RESULT IN UNINTENDED OR INTERRUPTED INSULIN DELIVERY." INTERRUPTED INSULIN DELIVERY HAS THE POTENTIAL TO RESULT IN HIGH BLOOD GLUCOSE LEVELS. "USER ERROR", THEREFORE, IS CONSIDERED TO BE A CONTRIBUTING FACTOR TO THE CUSTOMER'S REPORTED HIGH BG LEVELS. INSULET HAS INITIATED AN INTERNAL INVESTIGATION TO DETERMINE IF MARKETING CAN IMPROVE EDUCATION AND TRAINING RELATED TO THIS TOPIC. THE INVESTIGATION IS IN-PROCESS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER DAUGHTER'S BG LEVELS WENT HIGH AFTER A POD CHANGE. A BG OF 484MG/DL WITH HIGH KETONES WAS EXPERIENCED AND A CORRECTION BOLUS WAS ADMINISTERED. TWO HOURS LATER, HER BG LEVELS ROSE TO GREATER THAN 500MG/DL AND KETONES HAD INCREASED; THE POD WAS IMMEDIATELY DEACTIVATED. A MANUAL INSULIN INJECTION WAS ADMINISTERED AND A LITTLE OVER FOUR HOURS LATER, HER LEVELS HAD SUCCESSFULLY LOWERED TO 181MG/DL. NO POD ISSUE WAS REPORTED. THE DEVICE 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 CORP 11200 L30454

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other