Intended Use and Regulatory Information

About

LibreLinkUp, version 4.2

(01) 00357599824006

(10) 4.2 29 JUN 2022


Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502 USA

Intended Use

LibreLinkUp is intended for use by caregivers to assist people with diabetes in the review, analysis and evaluation of historical glucose meter data to support effective diabetes management.

In addition:

LibreView is a secondary viewer and is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

LibreLinkUp is not intended to be used by clinicians.

Patients should not rely on caregivers to notify them about low or high glucose.

Dosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system. This device is not intended to replace self-monitoring practices as advised by a physician.

Any problems with the mobile device, NFC, Bluetooth, wireless internet connection, mobile data connection, FreeStyle LibreLink, LibreLinkUp or LibreView could cause data to not be shared with caregivers, or delay transmission to caregivers.

LibreLinkUp should be used only to give a secondary level of awareness and should not be expected to always communicate and transfer sensor glucose information.