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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 7
BIGFOOT BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 1069 1069
2021 22500 22508
2022 26528 26558
2023 39323 39359
2024 35116 35122
2025 19770 19770

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 99866 99885
Unable to Obtain Readings 18015 18024
Device Displays Incorrect Message 17697 17707
High Readings 4940 4942
Low Readings 4767 4776
Detachment of Device or Device Component 4412 4413
Product Quality Problem 3807 3812
Device Alarm System 3360 3384
Adverse Event Without Identified Device or Use Problem 2721 2723
Failure to Power Up 947 948
Application Program Problem 504 519
Premature Discharge of Battery 243 250
Failure to Fire 152 152
Material Twisted/Bent 134 135
No Audible Alarm 130 137
No Device Output 124 124
Unintended Electrical Shock 109 109
Power Problem 95 95
Difficult to Insert 67 67
Appropriate Term/Code Not Available 65 65
Display or Visual Feedback Problem 56 56
Key or Button Unresponsive/not Working 53 53
Activation, Positioning or Separation Problem 51 51
Application Program Freezes, Becomes Nonfunctional 42 42
Battery Problem 39 39
Insufficient Information 35 35
No Display/Image 26 26
Component Missing 20 21
Break 18 18
Defective Device 17 18
Data Problem 16 16
Therapeutic or Diagnostic Output Failure 16 20
Device Damaged Prior to Use 14 14
Failure to Charge 14 14
Packaging Problem 13 13
No Apparent Adverse Event 12 12
Compatibility Problem 11 14
Audible Prompt/Feedback Problem 10 10
Use of Device Problem 10 11
Charging Problem 9 9
Difficult or Delayed Activation 8 8
Computer Software Problem 8 8
Shipping Damage or Problem 8 8
Erratic or Intermittent Display 8 8
Crack 8 8
Device Sensing Problem 7 9
Communication or Transmission Problem 7 7
Output Problem 7 7
No Audible Prompt/Feedback 7 7
Wireless Communication Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 103781 103807
Hypoglycemia 23190 23219
Loss of consciousness 17587 17611
Convulsion/Seizure 6739 6744
Hyperglycemia 4898 4909
Diaphoresis 4618 4623
Dizziness 3874 3881
Shaking/Tremors 2940 2943
Insufficient Information 2661 2672
Fatigue 2430 2432
Confusion/ Disorientation 1647 1647
Skin Infection 1515 1516
Pain 1072 1073
Skin Inflammation/ Irritation 1005 1005
Headache 985 985
Vomiting 797 797
Nausea 776 776
Blurred Vision 680 681
Erythema 510 511
No Known Impact Or Consequence To Patient 507 507
Hypersensitivity/Allergic reaction 426 426
Diabetic Ketoacidosis 420 420
Swelling/ Edema 383 383
Itching Sensation 336 336
Hemorrhage/Bleeding 297 299
Discomfort 293 293
Purulent Discharge 270 270
Muscle Weakness 257 258
Cognitive Changes 238 238
Polydipsia 227 228
Tachycardia 185 185
Abscess 157 157
Malaise 143 143
Fall 130 130
Bruise/Contusion 127 127
Device Embedded In Tissue or Plaque 126 126
Hot Flashes/Flushes 122 122
Rash 92 92
Dehydration 82 82
Numbness 79 79
Cramp(s) /Muscle Spasm(s) 78 78
Fever 74 74
Chills 72 72
Coma 66 66
Sweating 61 61
Burning Sensation 60 60
Lethargy 58 58
Seizures 49 49
Blister 48 48
Electric Shock 45 45

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