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Animas® Vibe® Insulin Pump & Continuous Glucose Monitoring System

<p>*Patients must confirm CGM reading with a fingerstick test before taking action.</p> <p>**CGM readings may not be transmitted from the CGM to the pump while in the water.</p> <p><strong>Important safety information</strong></p> <p>The Animas® Vibe® Insulin Pump and CGM System is intended for the delivery of insulin and for continuous glucose monitoring (CGM) for the management of insulin-requiring diabetes. The Animas® Vibe® System’s CGM, which includes the Dexcom G4® PLATINUM Sensor and Transmitter, is indicated for detecting trends and tracking patterns in persons age 2 and older. The system is intended for single patient use and requires a prescription.</p> <p>Contraindications: Insulin pump therapy is not recommended for people unwilling or unable to test their blood glucose four to six times per day, unwilling or unable to see their healthcare professional regularly, or whose vision or hearing does not allow recognition of pump alerts, warnings, and alarms. The Animas® Vibe® Insulin Pump must be removed before MRI or CT scan, and the Dexcom G4® PLATINUM Sensor and Transmitter must be removed before MRI, CT scan, or diathermy treatment. Taking acetaminophen-containing medications while wearing the sensor may falsely raise sensor glucose readings.</p> <p>Warnings: Connecting to the pump before receiving the necessary training could result in serious injury or death. Younger children may inadvertently press the pump buttons and deliver insulin, which can lead to hypoglycemic events. Caregivers are responsible for helping to ensure safe and effective delivery of insulin to people in their care, including using the safety features on the Animas Vibe System to help prevent injury. CGM glucose readings are not to be used to make treatment decisions. The sensor and transmitter do not replace a blood glucose meter. The sensor and transmitter are not to be used during pregnancy or while on dialysis. Sensor placement is only approved for sites under the skin of the belly (abdomen) in adults and the belly or upper buttocks for ages 2 to 17 (pediatrics). Patients should seek professional medical help if a sensor breaks and no portion of it is visible above the skin, or if there is infection or inflammation. Any broken sensors or adverse events should be reported to Customer Service. Contact Customer Service at 1-877-937-7867 or visit <a href="https://www.animas.com/safety">Important Safety Information</a> for detailed indications for use and safety information.</p>
NACO/GEN/0217/0118a