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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
BIGFOOT BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 22500 22508
2022 26528 26558
2023 39318 39354
2024 35108 35114
2025 20527 20527
2026 11360 11363

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 109144 109160
Unable to Obtain Readings 18138 18147
Device Displays Incorrect Message 17825 17834
Low Readings 5814 5816
High Readings 5148 5150
Detachment of Device or Device Component 4441 4441
Product Quality Problem 3917 3917
Device Alarm System 3374 3398
Adverse Event Without Identified Device or Use Problem 2882 2884
Failure to Power Up 957 958
Application Program Problem 517 529
Premature Discharge of Battery 245 246
Failure to Fire 155 155
Material Twisted/Bent 138 139
No Device Output 132 132
No Audible Alarm 118 125
Unintended Electrical Shock 115 115
Activation, Positioning or Separation Problem 109 109
Power Problem 94 94
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
Data Problem 16 16
No Apparent Adverse Event 15 15
Failure to Charge 14 14
Delivered as Unsterile Product 13 13
Packaging Problem 13 13
Device Damaged Prior to Use 11 11
Audible Prompt/Feedback Problem 11 11
Computer Software Problem 10 10
Charging Problem 10 10
Erratic or Intermittent Display 9 9
Difficult or Delayed Activation 9 9
Device Damaged Prior to Receipt by User 8 8
Use of Device Problem 8 8
No Audible Prompt/Feedback 7 7
Crack 7 7
Image Display Error/Artifact 6 6
Communication or Transmission Problem 6 6
Firing Problem 5 5
Output Problem 5 5
Compatibility Problem 5 5
Failure to Run on Battery 4 4
Appropriate Device Problem Term/Code Not Available 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 114551 114580
Hypoglycemia 23396 23425
Loss of consciousness 17738 17762
Convulsion/Seizure 6834 6839
Hyperglycemia 5012 5023
Diaphoresis 4738 4743
Dizziness 3942 3949
Shaking/Tremors 2980 2983
Insufficient Information 2793 2804
Fatigue 2519 2521
Confusion/ Disorientation 1661 1661
Skin Infection 1602 1603
Pain 1129 1130
Skin Inflammation/ Irritation 1068 1068
Headache 1010 1010
Vomiting 828 828
Nausea 783 783
Blurred Vision 706 707
Erythema 532 533
Elevated ketones/Diabetic Ketoacidosis 439 439
Hypersensitivity/Allergic reaction 436 436
Swelling/ Edema 415 415
Itching Sensation 351 351
Hemorrhage/Blood Loss/Bleeding 332 334
Discomfort 303 303
Purulent Discharge 278 278
Muscle Weakness/Atrophy 256 257
Cognitive Changes 254 254
Polydipsia 239 240
Tachycardia 186 186
Device Embedded In Tissue or Plaque 180 180
Abscess 166 166
Malaise 142 142
Bruise/Contusion 132 132
Hot Flashes/Flushes 126 126
Fall 123 123
Sleepiness/Drowsiness/Somnolence 106 106
Rash 100 100
Dehydration 92 92
Numbness 87 87
Fever 80 80
Cramp(s) /Muscle Spasm(s) 78 78
Chills 71 71
Burning Sensation 66 66
Coma 65 65
Lethargy 58 58
Blister 49 49
Urinary Frequency / Polyuria 43 43
Electric Shock 42 42
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 37 37

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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