BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2071826 · Received April 22, 2011

    Report

    Report Number
    3004464228-2011-00173
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 22, 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 RETURNED PRODUCT WAS EVALUATED AND NO MALFUNCTION OR MFG DEFICIENCY WAS DETECTED. THERE WAS, HOWEVER, AN AIR BUBBLE FOUND IN THE INSULIN RESERVOIR, WHICH TYPICALLY OCCURS DURING THE FILL PROCESS. 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 BLOOD GLUCOSE 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

    PT STATED HE HAD BLOOD GLUCOSE LAST NIGHT OF OVER 500 MG/DL AND TOOK A MANUAL INJECTION WHICH BROUGHT IT DOWN TO 320 MG/DL BEFORE HE REMOVED THE POD. HE THOUGH THE CANNULA MAY HAVE PULLED OUT OF HIS SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30448

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other