BEUDAMED
    FDA Recall 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 · Initiated July 21, 2014

    Recall

    Recall Number
    Z-2179-2014
    Event Number
    68888
    Firm
    Medtronic MiniMed Inc.
    FEI Number
    3003166194
    Product Code
    MDS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 21, 2014
    Posted
    August 10, 2014
    Terminated
    October 8, 2014
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    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.

    Action

    Medical Device Recall letters dated July 21, 2014 andJuly 22, 2014 were sent to distributors, patients, and healthcare providers who purchased the Guardian REAL time monitors. The letters inform the customers of the problems identified and the actions to be taken. Distributors with questions are instructed to email [email protected]. If healthcare professionals want to speak to Medtronic's medical officers then they are instructed to call (818) 576-4211, ext. 64511. Customers and healthcare professionals' patients are instructed to call Guardian Recall Hotline at (800) 646-4633, ext. 21090, 8am-6pm, CST.

    Distribution

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

    Quantity

    86 units