BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1790047 · Received July 30, 2010

    Report

    Report Number
    3004464228-2010-01213
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PDM WAS RETURNED AND EVALUATED. THE EVALUATION CONFIRMED A FAILURE OF THE LCD SCREEN WHICH IMPAIRED THE CUSTOMER'S ABILITY TO MONITOR HIS DIABETES AND ADMINISTER PROPER CARE. THE OMNIPOD USER GUIDE CAUTIONS: "DO NOT USE THE PDM IF IT APPEARS DAMAGED OR IS NOT WORKING AS IT SHOULD". IF USER GUIDE INSTRUCTIONS WERE PROPERLY FOLLOWED, THE USER WOULD HAVE DISCONTINUED USE AT THE FIRST SIGN OF DAMAGE TO THE LCD. IN THE REPORTED EVENT, THE CUSTOMER CONTINUED USING THE PDM TWO WEEKS AFTER INITIALLY NOTICING AN ISSUE WITH THE SCREEN.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER SON "WAS HAVING TROUBLE SEEING THINGS ON HIS PDM." SHE STATED THAT THE LCD SCREEN WAS "MOSTLY BLANK" AND THAT ONLY THE TOP 1/4 OF THE SCREEN COULD BE SEEN. SHE INDICATED, HOWEVER, THAT THE PDM "WAS NOT DROPPED OR STRESSED." (THIS CONDITION FIRST STARTED A COUPLE WEEKS PRIOR TO FOLLOWING REPORTED EVENT.) THE MOTHER ALSO REPORTED THAT HER SON HAD TAKEN SICK AND EXPERIENCED BG'S IN THE 500 MG/DL RANGE; MULTIPLE BOLUSES WERE ADMINISTERED BUT HIS LEVELS REMAINED HIGH. AS A RESULT, HE WAS TAKEN TO THE HOSP WHERE HE WAS DIAGNOSED WITH DKA. INFO FROM THE PDM WAS UNABLE TO BE OBTAINED DUE TO THE CONDITION OF THE LCD SCREEN. THE PDM WILL BE RETURNED FOR EVALUATION. (NOTE: THE POD WORN DURING THE TIME OF THE HIGH BG'S WAS NOT RETURNED FOR EVALUATION.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11360 L10978

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention