BEUDAMED
    FDA Recall Terminated

    Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.

    Recall: Z-2442-2015 · Initiated July 22, 2015

    Recall

    Recall Number
    Z-2442-2015
    Event Number
    71816
    Firm
    Medtronic MiniMed Inc.
    FEI Number
    3003166194
    Product Code
    MDS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 22, 2015
    Posted
    August 21, 2015
    Terminated
    September 18, 2015
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.

    Reason

    Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in Predictive Alerts setting: the on-screen Finnish translation for LOW/HIGH is reversed as HIGH/LOW.

    Action

    A Urgent Medical Device recall letter was sent to customers on 7/22/15 to inform them that the Guardian Real-Time Continuous Glucose Monitoring System System has a language translation error that impacts the Finnish language. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contact Nordic Support Line 0-800-164-064.

    Distribution

    Distributed in Finland.

    Quantity

    254 units