BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 21366341 · Received February 12, 2025

    Report

    Report Number
    3004464228-2025-06358
    Event Type
    Injury
    Date Received
    February 12, 2025
    Date of Event
    December 26, 2024
    Report Date
    February 12, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000213
    PMA / PMN Number
    K203768
    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: LOCKDOWN CLOUD - OMNIPOD 5 SOFTWARE APP VERSION: 3.1.1. CLOUD - SMARTPHONE OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06. CLOUD - SMARTPHONE HARDWARE: N5004L. CLOUD - CGM SENSOR TYPE: G6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT REPORTS HAVING A LOSS OF CONSCIOUSNESS WHILE WEARING A POD. ONCE AT THE HOSPITAL THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT. TREATMENT INFORMATION IS UNAVAILABLE. THE PATIENT WAS IN THE HOSPITAL INTENSIVE CARE UNIT FOR 26 DAYS. THE PATIENTS POD WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042590 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000536 PH1K11162351 10385083000213

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization