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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
Regulation Description Integrated continuous glucose monitoring system.
Definition An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems.
Product CodeQLG
Regulation Number 862.1355
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 6
  1.  K201761  FreeStyle Libre 2 Flash Glucose Monitoring System ...
  2.  K210943  FreeStyle Libre 2 Flash Glucose Monitoring System ...
  3.  K211102  FreeStyle Libre 2 Flash Glucose Monitoring System
  4.  K212132  FreeStyle Libre 3 Continuous Glucose Monitoring Sy ...
  5.  K213996  FreeStyle Libre 3 Continuous Glucose Monitoring Sy ...
  6.  K223537  FreeStyle Libre 2 System, FreeStyle Libre 3 System
BIGFOOT BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 22500 22508
2022 26528 26558
2023 39317 39353
2024 35108 35114
2025 20527 20527
2026 20407 20410

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 117797 117813
Unable to Obtain Readings 18185 18194
Device Displays Incorrect Message 17864 17873
Low Readings 5933 5935
High Readings 5189 5191
Detachment of Device or Device Component 4458 4458
Product Quality Problem 3925 3925
Device Alarm System 3394 3418
Adverse Event Without Identified Device or Use Problem 2930 2932
Failure to Power Up 962 963
Application Program Problem 517 529
Premature Discharge of Battery 245 246
Failure to Fire 155 155
Material Twisted/Bent 139 140
No Device Output 132 132
Activation, Positioning or Separation Problem 132 132
No Audible Alarm 118 125
Unintended Electrical Shock 115 115
Power Problem 97 97
Difficult to Insert 66 66
Display or Visual Feedback Problem 57 57
Key or Button Unresponsive/not Working 54 54
Application Program Freezes or Fails to Launch 42 42
Battery Problem 38 38
Insufficient Device Problem Information 37 37
No Display/Image 24 24
Component Missing 19 19
Break 17 17
No Apparent Adverse Event 16 16
Data Problem 16 16
Failure to Charge 14 14
Packaging Problem 13 13
Delivered as Unsterile Product 13 13
Audible Prompt/Feedback Problem 11 11
Device Damaged Prior to Use 11 11
Charging Problem 10 10
Erratic or Intermittent Display 9 9
Computer Software Problem 9 9
Difficult or Delayed Activation 9 9
Device Damaged Prior to Receipt by User 8 8
Use of Device Problem 8 8
Crack 7 7
No Audible Prompt/Feedback 7 7
Image Display Error/Artifact 6 6
Communication or Transmission Problem 6 6
Compatibility Problem 5 5
Firing Problem 5 5
Output Problem 5 5
Failure to Run on Battery 4 4
Material Separation 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 123317 123346
Hypoglycemia 23495 23524
Loss of consciousness 17796 17820
Convulsion/Seizure 6852 6857
Hyperglycemia 5062 5073
Diaphoresis 4758 4763
Dizziness 3958 3965
Shaking/Tremors 3000 3003
Insufficient Information 2825 2836
Fatigue 2536 2538
Confusion/ Disorientation 1667 1667
Skin Infection 1623 1624
Pain 1149 1150
Skin Inflammation/ Irritation 1084 1084
Headache 1019 1019
Vomiting 835 835
Nausea 789 789
Blurred Vision 710 711
Erythema 551 552
Elevated ketones/Diabetic Ketoacidosis 445 445
Hypersensitivity/Allergic reaction 436 436
Swelling/ Edema 428 428
Itching Sensation 354 354
Hemorrhage/Blood Loss/Bleeding 343 345
Discomfort 313 313
Purulent Discharge 284 284
Muscle Weakness/Atrophy 256 257
Cognitive Changes 255 255
Polydipsia 244 245
Device Embedded In Tissue or Plaque 191 191
Tachycardia 186 186
Abscess 167 167
Malaise 142 142
Bruise/Contusion 132 132
Hot Flashes/Flushes 127 127
Fall 123 123
Sleepiness/Drowsiness/Somnolence 107 107
Rash 102 102
Dehydration 93 93
Numbness 87 87
Fever 80 80
Cramp(s) /Muscle Spasm(s) 78 78
Chills 71 71
Burning Sensation 67 67
Coma 65 65
Lethargy 58 58
Blister 50 50
Urinary Frequency / Polyuria 46 46
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 43 43
Electric Shock 42 42

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. I Jan-14-2026
2 Abbott Diabetes Care, Inc. I Aug-27-2024
3 Abbott Diabetes Care, Inc. II Jan-16-2024
4 Abbott Diabetes Care, Inc. II Aug-17-2023
5 Abbott Diabetes Care, Inc. I Apr-06-2023
6 BIGFOOT BIOMEDICAL II Jun-20-2025
7 Cardinal Health Inc. II Jun-23-2021
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