Paradigm REAL-Time and Guardian REAL-Time Systems P980022/S015
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Paradigm REAL-Time and Guardian REAL-Time Systems
PMA Applicant: Medtronic MiniMed
Address:18000 Devonshire Street , Northridge, CA 91325- 9852
Approval Date: March 8, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p980022s015a.pdf
What is it? The Paradigm REAL-Time and Guardian REAL-Time Systems are glucose sensors that report glucose values every 5 minutes for up to 72 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults, ages 18 and over, and in children and adolescents, ages 7 to 17 who have diabetes.
How does it work?
The sensors are inserted in the abdomen. After a two-hour start-up period, the systems are calibrated with fingerstick measurements taken by a traditional glucose meter. After calibration, the Paradigm and Guardian REAL-Time systems provide glucose readings and updated glucose trend information for viewing every 5 minutes. The systems also contain built-in alarms that can be programmed to alert the user when results fall below ore-set low and pre-set high levels.
When is it used? The Paradigm REAL-Time and Guardian REAL-Time Systems are used with fingerstick measurements to provide additional glucose information to adults with diabetes, age 18 and over, children and adolescents with diabetes, age 7 to 17, and their healthcare practitioners.
What will it accomplish? Additional glucose information may help people with diabetes and their healthcare practitioners to better manage their disease by providing more information on glucose trends and patterns than can be obtained with fingerstick measurements alone.
When should it not be used?
- The Paradigm REAL-Time and Guardian REAL-Time Systems are not designed to replace blood glucose meters. They must be used with a blood glucose meter.
- Treatment decisions should not be made or changed based on results from these systems. You must confirm with a blood glucose meter before making therapeutic adjustments.
- Continuous glucose monitoring with these devices is not recommended for people who are unwilling or unable to perform a minimum of two meter blood glucose tests per day and to maintain contact with their healthcare practitioner.
- Successful monitoring with these devices requires sufficient vision and hearing to allow recognition of sensor signals and alarms.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p980022s015