Medical Devices

Dexcom G5 Mobile Continuous Glucose Monitoring System - P120005/S041

Image of the device.

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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Dexcom G5 Mobile Continuous Glucose Monitoring System
PMA Applicant: Dexcom, Inc.
Address: 6340 Sequence Drive, San Diego, CA, 92121, USA
Approval Date: December 20, 2016
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120005S041a.pdf

What is it? The Dexcom G5 Mobile Continuous Glucose Monitoring System (Dexcom G5) consists of an externally-worn glucose sensor that continuously measures glucose levels and displays the values. In addition to reporting glucose values every 5 minutes, the system reports trending information in real-time for up to seven days (the life of each sensor).

This supplement expands the indications for the Dexcom G5 to allow for replacement of fingerstick blood glucose testing for diabetes treatment decisions.

How does it work? This device uses a small flexible metal wire (sensor) that is inserted just below the skin where it generates a small electrical signal in response to the amount of sugar that is present (interstitial glucose). This electrical signal is converted into a blood glucose reading and transmitted wirelessly every 5 minutes to a dedicated receiver and/or compatible mobile device (smart phone, tablet, etc.) for display to a user. The system must be calibrated at least two times per day by testing a fingertip blood sample with a blood glucose meter.

When is it used? The Dexcom G5 is used for the management of diabetes in persons age 2 years and older. It is designed to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G5 results should be based on the glucose trends and several sequential readings over time. The Dexcom G5 also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G5 is intended for single patient use and requires a prescription.

What will it accomplish? People with diabetes can use the information from this device to make diabetes treatment decisions (for example, administer insulin or carbohydrates). Information from the device can also be used to help determine patterns in glucose levels and make long-term adjustments to diabetes treatment plans to keep blood glucose levels in a safe range. The system can alert users when glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels.

When should it not be used?

MRI/CT/ Diathermy
Remove the Dexcom G5 Sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The Dexcom G5 has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the components of the Dexcom G5, which might cause it to display inaccurate blood glucose readings or fail to provide alerts.

Medications
Taking medications with acetaminophen (such as Tylenol) while wearing the Dexcom G5 may falsely raise the glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and is different for each person. Do not rely on continuous glucose monitoring data produced by the Dexcom G5 if you have recently taken acetaminophen.

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling will be available online.

Page Last Updated: 12/21/2016
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