BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 21405797 · Received February 18, 2025

    Report

    Report Number
    3004464228-2025-06987
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 11, 2025
    Report Date
    February 18, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. 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. *PLEASE NOTE, THAT SECTION D IS CAPTURING THE DEVICE IDENTIFIERS AS REPORTED BY THE COMPLAINANT. THIS MAY NOT ALIGN TO THE DEVICE CONFIGURATION REPORTED IN H11, AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT. CLOUD - LOCKED DOWN/SMARTPHONE PHONE_CONTROL_ANDROID, CLOUD - OMNIPOD 5 SOFTWARE APP VERSION 3.1.1, CLOUD - SMARTPHONE OPERATING SYSTEM UP1A.231005. 007.S918USQS5CXJX, CLOUD - SMARTPHONE HARDWARE SM-S918U, CLOUD - CGM SENSOR TYPE G7.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 700 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA AND VOMITING. ONCE AT THE HOSPITAL THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT. THE PATIENT WAS TREATED WITH AN INSULIN DRIP. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL INTENSIVE CARE UNIT AFTER 13 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2669739 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1K05302411 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Hospitalization