Closex

Indications and Important Safety Information

INDICATIONS FOR USE

The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The System is intended for use by health care professionals and requires a prescription. Readings from the FreeStyle Libre Pro Sensor are only made available to patients through consultation with a health care professional. The System does not require user calibration with blood glucose values.The FreeStyle Libre Pro System aids in the detection of glucose level excursions above or below the desired range, facilitating therapy adjustments. Interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should be based on the trends and patterns analyzed through time using the reports available.

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

The FreeStyle Libre Pro Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in the user’s glucose values during the wear period.

WARNING: The FreeStyle Libre Pro Flash Glucose Monitoring System contains small parts that may be dangerous if swallowed.

CAUTION:

  • Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.
  • Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If your patient notices significant skin irritation around or under their Sensor, they should remove the Sensor and stop using the FreeStyle Libre Pro System. Follow your facility’s procedures for handling skin reactions.

Warnings/Limitations

  • Review all product information before use.
  • Physiologic differences between the interstitial fluid and capillary blood may result in differences in glucose readings. Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.
  • Severe dehydration and excessive water loss may cause inaccurate results.
  • Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause inaccurate results.
  • Interfering Substances: Taking ascorbic acid (vitamin C) while wearing the Sensor may falsely raise Sensor glucose readings. Taking salicylic acid (used in some pain relievers such as aspirin and some skin care products) may slightly lower Sensor glucose readings. The level of inaccuracy depends on the amount of the interfering substance active in the body. Test results did not indicate interference for methyldopa (used in some drugs to treat high blood pressure) or tolbutamide (infrequently used in some drugs to treat diabetes in the US) at maximum circulating levels. However, concentrations of potential interferents in interstitial fluid are unknown compared to circulating blood. Taking medications with acetaminophen (such as Tylenol and some cold medicines) while wearing the Sensor may falsely raise Sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in the body and may be different for each person.
  • Take standard precautions for transmission of blood borne pathogens to avoid contamination.
  • The Reader should be cleaned between patients.
  • If a Sensor breaks inside a patient, remove with tweezers, treat any medical complications and call Customer Service.
  • Use of the System is not recommended in the critically ill population since performance is unknown due to different conditions and medications.
  • Sensor placement is not approved for sites other than the back of the arm. If placed in other areas, the Sensor may not function properly.
  • If the Sensor Kit package or contents or the Reader appear to be damaged, do not use as there may be a risk of electric shock, no results, and/or infection.
  • Store the Sensor Kit between 39°F-77°F. While you don’t need to keep the Sensor Kit in a refrigerator, you can as long as the refrigerator is between 39°F-77°F.
  • Store the Sensor Kit between 10-90% non-condensing humidity.
  • The System does not provide real-time results. Patients need to rely on blood glucose readings for monitoring glucose during System use.
  • Clean hands prior to Sensor handling/insertion to help prevent infection.
  • Clean the application site and ensure that it is dry prior to Sensor insertion. This helps the Sensor stay attached to the body.
  • Change the application site for the next Sensor application to prevent discomfort or skin irritation.
  • Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). Choose a site that is at least 1 inch away from an insulin injection site.
  • The Sensor should not be worn more than 14 days. Readings are not obtained after 14 days.
  • The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the system has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in the user’s glucose values during the wear period.
  • The FreeStyle Libre Pro Flash Glucose Monitoring System has not been evaluated for use in pregnant women, persons on dialysis, or people less than 18 years of age.