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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 10384 10384

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 91967 91967
Unable to Obtain Readings 17779 17779
Device Displays Incorrect Message 17480 17480
High Readings 4738 4738
Detachment of Device or Device Component 4392 4392
Low Readings 4330 4330
Product Quality Problem 3700 3700
Device Alarm System 3296 3296
Adverse Event Without Identified Device or Use Problem 2588 2588
Failure to Power Up 937 937
Application Program Problem 478 478
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 97 97
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 46 46
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
Failure to Charge 14 14
Device Damaged Prior to Use 14 14
Packaging Problem 13 13
Compatibility Problem 11 11
Audible Prompt/Feedback Problem 10 10
No Apparent Adverse Event 10 10
Use of Device Problem 9 9
Charging Problem 9 9
Erratic or Intermittent Display 8 8
Shipping Damage or Problem 8 8
Crack 8 8
Computer Software Problem 8 8
Difficult or Delayed Activation 8 8
Application Program Freezes, Becomes Nonfunctional 8 8
Output Problem 7 7
No Audible Prompt/Feedback 7 7
Device Sensing Problem 6 6
Communication or Transmission Problem 6 6
Firing Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 95657 95657
Hypoglycemia 22736 22736
Loss of consciousness 17196 17196
Convulsion/Seizure 6626 6626
Hyperglycemia 4661 4661
Diaphoresis 4513 4513
Dizziness 3771 3771
Shaking/Tremors 2869 2869
Insufficient Information 2594 2594
Fatigue 2338 2338
Confusion/ Disorientation 1596 1596
Skin Infection 1428 1428
Pain 1020 1020
Headache 961 961
Skin Inflammation/ Irritation 960 960
Vomiting 730 730
Nausea 729 729
Blurred Vision 660 660
No Known Impact Or Consequence To Patient 507 507
Erythema 474 474
Hypersensitivity/Allergic reaction 417 417
Diabetic Ketoacidosis 385 385
Swelling/ Edema 351 351
Itching Sensation 316 316
Hemorrhage/Bleeding 283 283
Discomfort 280 280
Muscle Weakness 257 257
Purulent Discharge 253 253
Cognitive Changes 232 232
Polydipsia 208 208
Tachycardia 173 173
Abscess 146 146
Malaise 143 143
Fall 130 130
Bruise/Contusion 123 123
Device Embedded In Tissue or Plaque 120 120
Hot Flashes/Flushes 115 115
Rash 87 87
Cramp(s) /Muscle Spasm(s) 78 78
Dehydration 77 77
Chills 72 72
Fever 70 70
Numbness 69 69
Sweating 61 61
Lethargy 57 57
Coma 55 55
Burning Sensation 51 51
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 Cardinal Health Inc. II Jun-23-2021
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