BEUDAMED
    FDA Recall Terminated

    Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

    Recall: Z-1203-2021 · Initiated February 1, 2021

    Recall

    Recall Number
    Z-1203-2021
    Event Number
    87305
    FEI Number
    3014585508
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 1, 2021
    Terminated
    February 8, 2023
    Address
    Insulet Corporation 100 Nagog Park, Acton, MA, 01720-3440

    Description

    Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

    Reason

    Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the User Guide, the text states that the comma (,) is not used for the decimal on the PDM, when in fact it is the period (.) that is not used.If a user were to use the period as a decimal separator when entering a bolus value, this decimal separator would not be recognized by the device and any numbers entered after the period could result in a larger value than intended

    Action

    Insulet issued Email, mail, or outbound call notification of the Field Safety Notification between Feb 2nd and Feb 5 th to end customers, HCPs and distributors in: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland. Letter states reason for correction, health risk and action to take: Please refer to the attached Annex in reference to page 6 of the User Guide as opposed to referring to the instructions in the existing User Guide. We recommend you place this insert at p.6 in your User Guide. Please ensure that the comma is always used when entering bolus values. In accordance with applicable rules, this corrective action is implemented with the knowledge of the relevant competent authorities. Please electronically confirm your understanding of this Field Safety Notification by going to the webpage the link below and following the instructions on screen.

    Distribution

    Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

    Quantity

    21,723 guides