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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 39320 39356
2024 35116 35122
2025 20535 20535
2026 1868 1868

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 100962 100981
Unable to Obtain Readings 17981 17990
Device Displays Incorrect Message 17666 17676
Low Readings 5265 5274
High Readings 4966 4968
Detachment of Device or Device Component 4385 4386
Product Quality Problem 3872 3877
Device Alarm System 3316 3340
Adverse Event Without Identified Device or Use Problem 2778 2780
Failure to Power Up 948 949
Application Program Problem 509 524
Premature Discharge of Battery 242 249
Failure to Fire 151 151
Material Twisted/Bent 135 136
No Device Output 128 128
No Audible Alarm 118 125
Unintended Electrical Shock 112 112
Power Problem 93 93
Difficult to Insert 66 66
Display or Visual Feedback Problem 56 56
Key or Button Unresponsive/not Working 54 54
Activation, Positioning or Separation Problem 53 53
Application Program Freezes, Becomes Nonfunctional 42 42
Battery Problem 38 38
Insufficient Information 35 35
No Display/Image 24 24
Component Missing 20 21
Break 18 18
Defective Device 17 18
Therapeutic or Diagnostic Output Failure 17 21
Data Problem 16 16
Failure to Charge 14 14
Device Damaged Prior to Use 13 13
No Apparent Adverse Event 13 13
Packaging Problem 13 13
Compatibility Problem 12 15
Audible Prompt/Feedback Problem 10 10
Charging Problem 10 10
Use of Device Problem 10 11
Difficult or Delayed Activation 9 9
Computer Software Problem 8 8
Erratic or Intermittent Display 8 8
Shipping Damage or Problem 8 8
Crack 7 7
Device Sensing Problem 7 9
Output Problem 7 7
No Audible Prompt/Feedback 7 7
Delivered as Unsterile Product 7 7
Image Display Error/Artifact 6 6
Wireless Communication Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 105915 105941
Hypoglycemia 23090 23119
Loss of consciousness 17555 17579
Convulsion/Seizure 6778 6783
Hyperglycemia 4882 4893
Diaphoresis 4660 4665
Dizziness 3867 3874
Shaking/Tremors 2929 2932
Insufficient Information 2690 2701
Fatigue 2448 2450
Confusion/ Disorientation 1640 1640
Skin Infection 1552 1553
Pain 1076 1077
Skin Inflammation/ Irritation 1027 1027
Headache 990 990
Vomiting 809 809
Nausea 766 766
Blurred Vision 681 682
Erythema 512 513
Hypersensitivity/Allergic reaction 430 430
Diabetic Ketoacidosis 424 424
Swelling/ Edema 396 396
Itching Sensation 335 335
Hemorrhage/Bleeding 306 308
Discomfort 297 297
Purulent Discharge 266 266
Muscle Weakness 256 257
Cognitive Changes 243 243
Polydipsia 229 230
Tachycardia 185 185
Abscess 160 160
Malaise 142 142
Device Embedded In Tissue or Plaque 128 128
Bruise/Contusion 127 127
Fall 123 123
Hot Flashes/Flushes 123 123
Rash 94 94
Dehydration 86 86
Numbness 83 83
Fever 79 79
Cramp(s) /Muscle Spasm(s) 78 78
Chills 71 71
Coma 63 63
Burning Sensation 61 61
Lethargy 58 58
Blister 48 48
Electric Shock 42 42
Urinary Frequency 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Balance Problems 26 26

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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