BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 21504269 · Received March 3, 2025

    Report

    Report Number
    3004464228-2025-08669
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 2, 2025
    Report Date
    March 3, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    Product Problem
    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. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO 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. CLOUD - LOCKED DOWN/SMARTPHONE PHONE_CONTROL_ANDROID. CLOUD - OMNIPOD 5 SOFTWARE APP VERSION 3.1.1. CLOUD - SMARTPHONE OPERATING SYSTEM TQ3A.230901. 001.C2. CLOUD - SMARTPHONE HARDWARE PIXEL 7. CLOUD - CGM SENSOR TYPE G6. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVELS (BG) ROSE TO OVER 250 MG/DL, WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, THE PATIENT CHANGED OUT THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634595 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1K05242431 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female