BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 22848317 · Received August 20, 2025

    Report

    Report Number
    3004464228-2025-37310
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    June 21, 2025
    Report Date
    August 20, 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

    NO TIMEOUTS OR DRIVE STALLS WERE OBSERVED. THE EXPOSED PORTION OF THE SOFT CANNULA WAS OBSERVED TO BE TORN, WHERE IT WAS SEEN TO LEAK. THE TIMING AND CAUSE OF THE CANNULA TEAR COULD NOT BE DETERMINED. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_ANDROID. OMNIPOD SOFTWARE APP VERSION: 3.1.1. OPERATING SYSTEM: TP1A.220624. 014.G986U1UESCHYC1. HARDWARE: SM-G986U1. CGM SENSOR TYPE: G7. PLEASE NOTE, THE DEVICE IDENTIFIERS ARE CAPTURED AS REPORTED BY THE COMPLAINANT AND MAY NOT ALIGN WITH THE DEVICE CONFIGURATION REPORTED IN THIS SECTION 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 LEVEL ROSE TO 400 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS ON THE BACK. THE DEVICE WAS ORIGINALLY REPORTED FOR NOT SURE INSULIN WAS BEING DELIVERED. TREATMENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468532 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U12122431 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male