Abbott FreeStyle Libre 3

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* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.

† Levels out of System dynamic range.

Table 3c: Concurrence Analysis by YSI Glucose Level (Adult; n=200)

† Levels out of System dynamic range.

Table 3d: Concurrence Analysis by YSI Glucose Level (Pediatric*; n=168)

DOC44383_rev-C 1:14pm 22-SEP-2021

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Important Safety Information2
Indications for Use3
Important Safety Information3
Compatible Devices, Apps, and Software4
Contraindications4
Warnings4
How to Store the Sensor Kit8
When Not to Use the System8
What to Know about the System8
What to Know before You Apply the Sensor8
What to Know about X-Rays9
When to Remove the Sensor9
When Is Sensor Glucose Different from Blood Glucose9
Interfering Substances10
App Symbols10
Getting to Know Your System12
Sensor Kit13
Freestyle Libre 3 App14
Home Screen15
Reporting Software16
Setting up Your System for the First Time16
Applying Your Sensor17
Starting Your Sensor23
Checking Your Glucose25
Understanding Your Glucose Readings27
Glucose Trend Arrow27
Messages28
Making Treatment Decisions30
Making Treatment Decisions – Getting Started31
Helpful Tips32
Think Your Readings Are Incorrect?34
Symptoms Don’t Match Readings34
When to Do Nothing and Check Again Later34
Using Your Glucose Reading to Make a Treatment Decision35
Treatment Decision Considerations for Glucose Trend Arrow36
Other Considerations50
Meal Dosing50
High Glucose Corrections50
Bedtime50
App Alarms51
Optional Glucose Alarms51
Urgent Low Glucose51
Optional Signal Loss Alarm51
Fixed System Alarms52
Setting App Alarms54
Low Glucose Alarm54
High Glucose Alarm55
Signal Loss Alarm56
Using App Alarms57
Urgent Low Glucose Alarm57
Adding Notes59
App Stopped Alarm59
Reviewing Your History60
Logbook60
Other History Options61
Time in Ranges61
Low Glucose Events61
Average Glucose61
Sensor Usage62
Glucose Management Indicator62
Removing Your Sensor62
Replacing Your Sensor63
Using Reminders64
Living with Your System66
Activities66
Bathing, Showering, and Swimming66
Traveling by Air66
Settings and Other Menu Options67
App Settings67
Account Settings67
Connected Apps67
Maintenance and Disposal68
Troubleshooting68
Problems at the Sensor Application Site68
The Sensor Is Not Sticking to Your Skin69
Skin Irritation at the Sensor Application Site69
Problems Starting Your Sensor69
Scan Error69
Enable Bluetooth70
Incompatible Sensor70
Replace Sensor70
Allow Access to Critical Alerts70
Sensor Ready in X Minutes71
Check Sensor71
Sensor Ended71
Signal Loss71
Bluetooth off72
Sensor Error72
Sensor too Hot72
Sensor too Cold72
Problems Receiving Alarms73
Unexpected Application Error73
System Specifications75
Labeling Symbols76
Quality of Service (Qos)76
Performance Characteristics78
Overview of Clinical Studies78
Accuracy79
Accuracy to YSI Within CGM Glucose Ranges80
Accuracy to YSI Within YSI Glucose Ranges81
Agreement with ‘LO’ and ‘HI’ CGM Reading against YSI Reference81
Concurrence Analysis with ‘LO’ CGM Reading82
Concurrence Analysis with ‘HI’ CGM Reading82
Concurrence of System and Reference (CGM Vs. YSI)83
Concurrence Analysis by CGM Glucose Level83
Glucose Rate of Change Accuracy85
Concurrence Analysis by Glucose Rate of Change85
Alarm Performance86
Low Glucose Alarm Performance86
True Alarm Rate86
False Alarm Rate86
Missed Detection Rate87
High Glucose Alarm Performance88
Detection Rate88
Sensor Accuracy over Time90
Sensor Wear Duration90
Sensor Survival Rate over Wear Duration91
Glucose Reading Availability91
Precision92
Adverse Events92
Overall between Sensor Precision92
Ascorbic Acid Interference93
Additional Notes for Health Care Professionals93
Electromagnetic Compatibility (EMC)93

Abbott FreeStyle Libre 3 - Page 84

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