BEUDAMED
    FDA Enforcement Class II Terminated

    Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

    Recall: Z-2164-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2164-2020
    Event ID
    85552
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Insulet Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 10, 2020
    Initiation Date
    April 2, 2020
    Classification Date
    May 29, 2020
    Termination Date
    September 14, 2021
    Address
    100 Nagog Park, N/A, Acton, MA, 01720-3440, United States

    Description

    Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

    Reason

    After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.

    Code Info

    UDI: PT - 000010 - 10385082000139; Lot Numbers: L000202

    Distribution

    The products were distributed to the following foreign countries: Italy, Netherlands, UK.

    Quantity

    400