Safety Information

Indication for use

The SEVEN PLUS Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The SEVEN PLUS System is intended for use by patients at home and in health care facilities. The device is for prescription use only.

The SEVEN PLUS Continuous Glucose Monitoring System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.

The SEVEN PLUS Continuous Glucose Monitoring System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the SEVEN PLUS System results should be based on the trends and patterns seen with several sequential readings over time.

Contraindications

The SEVEN PLUS System must be removed prior to Magnetic Resonance Imaging (MRI).

Use of acetaminophen-containing medications while the SEVEN Sensor is inserted may affect the performance of the device.

Warnings

This device is not designed to replace a blood glucose meter. The SEVEN PLUS must be used with a blood glucose meter.

Treatment decisions should not be based solely on results from the SEVEN PLUS. You must confirm with a blood glucose meter before making therapeutic adjustments.

Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, use your blood glucose meter to check the SEVEN PLUS results.

You should update the SEVEN PLUS’ calibration every 12 hours at a minimum. The performance of the SEVEN PLUS System when calibrated less frequently than every 12 hours has not been studied.

Sensors fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department.

The SEVEN and SEVEN PLUS Systems are not approved for use in children or adolescents, pregnant women or persons on dialysis.

The safety and effectiveness of the SEVEN and SEVEN PLUS Systems have not been evaluated for sensor probe insertion sites other than the skin of the abdomen.

Precautions

Always wash hands with soap and water before opening the Sensor package. After opening the package, avoid touching the adhesive area.

Before inserting the Sensor, always clean the skin at the Sensor insertion location with a topical antimicrobial solution such as isopropyl alcohol. Do not apply the Sensor until the cleaned area is dry.

Establish a rotation schedule for choosing each new Sensor location. Avoid Sensor locations that are constrained by clothing, accessories, or subjected to rigorous movement during exercise.

Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of a Sensor.

The Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if its sterile package has been previously damaged or opened.

For OpenChoice Calibration you must enter the exact fingerstick reading that your blood glucose meter displays. Enter all fingerstick readings for calibration within 5 minutes. Entering incorrect fingerstick readings that occurred more than 5 minutes ago will affect device performance.

Please note, the performance characteristics section of the SEVEN PLUS User’s Guide has changed to reflect the recent study done. The overall results of the trial showed that SEVEN PLUS System will provide you more continuous glucose readings, and you should expect more of your Sensors to provide data for the entire 7-day use period. Note that the data described in the Performance Section also showed a difference from the SEVEN PLUS to the original SEVEN device in performance in the low glucose region (40-80 mg/dL). Our study showed that at 50 mg/dL blood glucose, the device reported glucose to be as high as 64 mg/dL and at 80 mg/dL blood glucose; the device reported glucose to be as high as 90 mg/dL. Because the performance of the SEVEN PLUS System varies from the original, it is important that you assess how the new generation device performs for you, especially in the low range. You should review the performance of this device with your healthcare provider to understand how well the SEVEN PLUS System performs.