Important Safety Information
1. There is no cure for Parkinson’' disease (PD) and essential tremor (ET), but there are options available to treat symptoms. The first-line therapy is medication. Surgical treatments are also available. It’' important to discuss with your doctor what's right for you along with the risks and side effects of each option, such as motor fluctuations or permanent neurological impairment.
As with any surgery or therapy, deep brain stimulation has risks and complications. Most side effects of DBS surgery are temporary and correct themselves over time. Some people may experience lasting, stroke-like symptoms, such as weakness, numbness, problems with vision or slurred speech. In the event that the side effects are intolerable or you are not satisfied with the therapy, the DBS system can be turned off or surgically removed.
Risks of brain surgery include serious complications such as coma, bleeding inside the brain, paralysis, seizures and infection. Some of these may be fatal.
2. A fingerstick test using a glucometer is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels; or if hypoglycemia or impending hypoglycemia is reported by the system; or when symptoms do not match the system readings.
The FreeStyle Libre Flash Glucose Monitoring system is a continuous glucose monitoring (CGM) device indicated for replacing blood glucose testing and detecting trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription.
CONTRAINDICATIONS:
Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment.
WARNINGS/LIMITATIONS:
Do not ignore symptoms that may be due to low or high blood glucose, hypoglycemic unawareness, or dehydration. Check sensor glucose readings with a blood glucose meter when Check Blood Glucose symbol appears, when symptoms do not match system readings, or when readings are suspected to be inaccurate. The FreeStyle Libre system does not have alarms unless the sensor is scanned, and the system contains small parts that may be dangerous if swallowed. The FreeStyle Libre system is not approved for pregnant women, persons on dialysis, or 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. The built-in blood glucose meter is not for use on dehydrated, hypotensive, in shock, hyperglycemic-hyperosmolar state, with or without ketosis, neonates, critically-ill patients, or for diagnosis or screening of diabetes. Review all product information before use or contact Abbott Toll Free (855-632-8658) or visit www.freestylelibre.us for detailed indications for use and safety information.