BEUDAMED
    FDA Enforcement Class I Ongoing

    Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.

    Recall: Z-0591-2024 · Reported January 10, 2024

    Enforcement

    Recall Number
    Z-0591-2024
    Event ID
    93511
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Insulet Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 10, 2024
    Initiation Date
    November 30, 2023
    Classification Date
    January 4, 2024
    Address
    50 & 100 Nagog Park, N/A, Acton, MA, 01720-3440, United States

    Description

    Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.

    Reason

    The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.

    Code Info

    UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10385083000206

    Distribution

    Worldwide distribution - US Nationwide and the countries of Germany and UK.

    Quantity

    27000 users