BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 23081794 · Received September 18, 2025

    Report

    Report Number
    3004464228-2025-42598
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    September 6, 2025
    Report Date
    September 18, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    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 HOSPITALIZATION AND DIABETIC KETOACIDOSIS. 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 HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2025. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 30.2 MMOL/L (544 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, CHEST PAIN, DEHYDRATED LIPS, BLOOD PRESSURE OF 153/119 AND HEART RATE OF 127 BEATS PER MINUTE. THE PATIENT WAS TREATED WITH INSULIN, DEXTROSE, SALINE SOLUTION, AND RINGER LACTATE (DOSES, FREQUENCY, AND ROUTES WERE NOT SPECIFIED). IT WAS UNSPECIFIED WHEN THE POD WAS REMOVED BUT IT WAS FOUND TO BE LEAKING INSULIN. A NEW POD WAS SUCCESSFULLY PLACED PRIOR TO THE PATIENT LEAVING THE HOSPITAL. THE PATIENT WAS RELEASED THE FOLLOWING DAY (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705711 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 40160 L72516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization