Indications and Important Safety Information
The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns and glucose level excursions above or below the desired range, facilitating therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for use by health care professionals and requires a prescription.
IMPORTANT: The device may inaccurately indicate hypoglycemia. The results of the clinical study conducted for this device showed that 40% of the time when the device indicated that user sensor glucose values were at or below 60 mg/dL, user glucose values were actually in the range of 81-160 mg/dL. Therefore, interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should only be based on the trends and patterns analyzed through time using the reports available per the intended use.
CONTRAINDICATIONS: Remove the Sensor before MRI, CT scan, X-ray, or diathermy treatment.
WARNINGS/LIMITATIONS: The FreeStyle Libre Pro System does not provide real-time results and patients should adhere to their blood glucose monitoring routine while using the system. If a sensor breaks, contact physician and call Customer Service. Patients with high levels of ascorbic acid (Vitamin C) or salicylic acid (used in Aspirin) or severe dehydration or excessive water loss or medications containing acetaminophen (Tylenol) may experience inaccurate results with this system. The FreeStyle Libre Pro System is not approved for pregnant women, persons on dialysis, or recommended for critically ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of blood borne pathogens should be taken. Review all product information before use or contact Abbott toll-free (855-632-5297) or visit www.FreeStyleLibrePro.us for detailed indications for use and safety information. FreeStyle Libre Pro and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions. © 2017 Abbott. ADC-04713 v1.0 04/17