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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
ABBOTT DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIGFOOT BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 1069 1069
2021 22500 22500
2022 26543 26543
2023 39502 39502
2024 35151 35151
2025 12492 12492

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 93779 93779
Unable to Obtain Readings 17845 17845
Device Displays Incorrect Message 17547 17547
High Readings 4792 4792
Low Readings 4426 4426
Detachment of Device or Device Component 4403 4403
Product Quality Problem 3713 3713
Device Alarm System 3306 3306
Adverse Event Without Identified Device or Use Problem 2625 2625
Failure to Power Up 938 938
Application Program Problem 481 481
Premature Discharge of Battery 241 241
Failure to Fire 152 152
Material Twisted/Bent 134 134
No Audible Alarm 130 130
No Device Output 122 122
Unintended Electrical Shock 101 101
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 50 50
Activation, Positioning or Separation Problem 47 47
Battery Problem 39 39
Insufficient Information 32 32
No Display/Image 26 26
Component Missing 20 20
Break 18 18
Data Problem 16 16
Defective Device 16 16
Therapeutic or Diagnostic Output Failure 15 15
Device Damaged Prior to Use 14 14
Failure to Charge 14 14
Packaging Problem 13 13
No Apparent Adverse Event 11 11
Compatibility Problem 11 11
Audible Prompt/Feedback Problem 10 10
Use of Device Problem 9 9
Charging Problem 9 9
Computer Software Problem 8 8
Crack 8 8
Erratic or Intermittent Display 8 8
Application Program Freezes, Becomes Nonfunctional 8 8
Shipping Damage or Problem 8 8
Difficult or Delayed Activation 8 8
Device Sensing Problem 7 7
Output Problem 7 7
No Audible Prompt/Feedback 7 7
Communication or Transmission Problem 6 6
Application Program Version or Upgrade Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 97500 97500
Hypoglycemia 22859 22859
Loss of consciousness 17299 17299
Convulsion/Seizure 6656 6656
Hyperglycemia 4719 4719
Diaphoresis 4542 4542
Dizziness 3796 3796
Shaking/Tremors 2882 2882
Insufficient Information 2610 2610
Fatigue 2359 2359
Confusion/ Disorientation 1603 1603
Skin Infection 1447 1447
Pain 1036 1036
Skin Inflammation/ Irritation 973 973
Headache 969 969
Nausea 741 741
Vomiting 740 740
Blurred Vision 664 664
No Known Impact Or Consequence To Patient 507 507
Erythema 478 478
Hypersensitivity/Allergic reaction 423 423
Diabetic Ketoacidosis 392 392
Swelling/ Edema 356 356
Itching Sensation 318 318
Hemorrhage/Bleeding 288 288
Discomfort 286 286
Purulent Discharge 257 257
Muscle Weakness 257 257
Cognitive Changes 231 231
Polydipsia 212 212
Tachycardia 174 174
Abscess 147 147
Malaise 143 143
Fall 130 130
Bruise/Contusion 124 124
Device Embedded In Tissue or Plaque 122 122
Hot Flashes/Flushes 116 116
Rash 87 87
Cramp(s) /Muscle Spasm(s) 78 78
Dehydration 77 77
Chills 72 72
Numbness 71 71
Fever 70 70
Sweating 61 61
Lethargy 57 57
Coma 57 57
Burning Sensation 54 54
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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