BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The information provided by these devices is intended for use in identifying potential episodes of high or low blood glucose. The information provided is not intended to be used directly for making therapy adjustment but rather to assist the user in determining that an additional fingerstick glucose measurement may be appropriate. Per the product labeling, all therapy adjustments should be based on fingerstick glucose measurements obtained using standard home glucose meters and not on the sensor glucose values provided by the Guardian REAL-Time monitor. The CSS7100 and CSS7100K monitors are identical expect for the fact that the CSS7100K monitor is a pediatric version that has a minimum programmable low alert setting of 90 mg/dL. The minimum programmable low glucose alert setting for the adult model (CSS7100) is 40 mg/dL.

    Recall: Z-2179-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2179-2014
    Event ID
    68888
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic MiniMed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2014
    Initiation Date
    July 21, 2014
    Classification Date
    August 9, 2014
    Termination Date
    October 8, 2014
    Address
    18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States

    Description

    Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The information provided by these devices is intended for use in identifying potential episodes of high or low blood glucose. The information provided is not intended to be used directly for making therapy adjustment but rather to assist the user in determining that an additional fingerstick glucose measurement may be appropriate. Per the product labeling, all therapy adjustments should be based on fingerstick glucose measurements obtained using standard home glucose meters and not on the sensor glucose values provided by the Guardian REAL-Time monitor. The CSS7100 and CSS7100K monitors are identical expect for the fact that the CSS7100K monitor is a pediatric version that has a minimum programmable low alert setting of 90 mg/dL. The minimum programmable low glucose alert setting for the adult model (CSS7100) is 40 mg/dL.

    Reason

    Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors.

    Code Info

    CSS7100 and CSS7100K

    Distribution

    Worldwide:Distribution - US Nationwide and the countries of Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, Switzerland.

    Quantity

    86 units