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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic MiniMed Guardian Monitor

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 Class 2 Recall
Medtronic MiniMed Guardian Monitor
see related information
Date Posted August 10, 2014
Recall Status1 Open
Recall Number Z-2179-2014
Recall Event ID 68888
Premarket Approval
PMA Number
P980022
Product Classification Sensor, Glucose, Invasive - Product Code MDS
Product 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.
Code Information CSS7100 and CSS7100K
Recalling Firm/
Manufacturer
Medtronic MiniMed Inc.
18000 Devonshire St
Northridge, California 91325-1219
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Device Design
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 rs.nrdlrinbox@medtronic.com. 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.
Quantity in Commerce 86 units
Distribution Worldwide:Distribution - US Nationwide and the countries of Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, Switzerland.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MDS and Applicant = MEDTRONIC INC.
PMAs with Product Code = MDS and Applicant = MEDTRONIC MINIMED
PMAs with Product Code = MDS and Applicant = MEDTRONIC MINIMED, INC.
PMAs with Product Code = MDS and Applicant = MINIMED, INC.
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