BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 19409924 · Received May 28, 2024

    Report

    Report Number
    3004464228-2024-19605
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    May 21, 2024
    Report Date
    June 18, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE CASE DESCRIPTION, THE USER MENTIONED GETTING A WHITE SCREEN AND BEING UNABLE TO USE THE PDM. ON BOOTING UP THE RETURNED PDM, THE DEVICE WAS ABLE TO GET PAST THE INITIAL DASH SPLASH SCREEN TO THE LOCK SCREEN AND WAS ABLE TO BE UNLOCKED. ON UNLOCKING THE DEVICE, A RESET CLOCK ALARM WAS GENERATED AND THE DATE AND TIME WERE ABLE TO BE SUCCESSFULLY SET. ONCE THE DATE AND TIME WERE CHANGED, THE PDM WAS UNABLE TO GET TO THE MAIN MENU AS THE DEVICE LOADED TO A WHITE SCREEN WITH A VISIBLE TOP BANNER AND BEGAN TO SWITCH AND REFRESH BETWEEN WHITE SCREENS. THE DEVICE CONTINUOUSLY SWAPPED BETWEEN WHITE SCREENS AND WAS UNABLE TO REACH TO MAIN MENU. NO FURTHER INVESTIGATION COULD BE COMPLETED. AN IBF FILE WAS ABLE TO BE DOWNLOADED, HOWEVER NO RECENT ANDROID LOG FILES COULD BE DOWNLOADED. INSPECTION OF THE IBF FOUND NO ISSUES THAT WOULD CONTRIBUTE TO THE LOOPING WHITE SCREENS. THE EXACT CAUSE OF THIS LOOPING WHITE SCREEN DASH PDM SOFTWARE FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITAL VISIT AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL WITH HYPERGLYCEMIA. THE PATIENT REPORTED THE PDM (PERSONAL DIABETES MANAGER) SCREEN TURNED WHITE, RESULTING IN THE PATIENT'S INABILITY TO DELIVER INSULIN VIA THE OMNIPOD SYSTEM. THE PATIENT REPORTED NOT HAVING AN ALTERNATIVE FORM OF INSULIN DELIVERY WITH SYRINGES AND/OR PENS, SO THEY WENT TO THE HOSPITAL FOR ASSISTANCE. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED >250 MG/DL. NO SPECIFIC SYMPTOMS RELATED TO HYPERGLYCEMIA WERE PROVIDED. THE PATIENT WAS INITIALLY TREATED WITH 10 UNITS OF INSULIN, THEN LATER GIVEN AN ADDITIONAL 15 UNITS OF INSULIN WHEN THE BG (BLOOD GLUCOSE) LEVELS DID NOT DECREASE. THE PATIENT WAS RELEASED IN 3-4 HOURS AND CONTINUES ON INSULIN INJECTIONS WHILE AWAITING A PDM REPLACEMENT. THE POD WAS REMOVED PRIOR TO HOSPITAL VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239186 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18239 L000458

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Hospitalization