BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2151617 · Received June 29, 2011

    Report

    Report Number
    3004464228-2011-00314
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 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 THOROUGHLY EVALUATED AND NO EVIDENCE OF ANY MALFUNCTION OR MANUFACTURING 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 MANUFACTURING PROCESS ISSUE OR PRODUCT DEFECT. "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 EXPERIENCED CONSISTENTLY HIGH BG LEVELS OVER THE 2.5 DAYS THE POD WAS WORN. DURING THIS TIME, MULTIPLE BOLUSES HAD BEEN ADMINISTERED, THOUGH HER LEVELS REMAINED HIGH (304-390MG/DL). SHE "NOTICED THAT THE CANNULA WAS PULLED OUT OF HER SKIN"; NO POTENTIAL CAUSE OF THE CANNULA PULLING FROM HER SKIN WAS NOTED. SHE "DOES NOT USE ANYTHING EXTRA TO HELP THE POD STICK OR PROTECT IT FROM TUGGING ON CLOTHES." THE POD WAS DEACTIVATED AND 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 L30471

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other