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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
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 39513 39513
2024 23579 23579

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 75493 75493
Unable to Obtain Readings 15763 15763
Device Displays Incorrect Message 15584 15584
Detachment of Device or Device Component 4062 4062
High Readings 3888 3888
Product Quality Problem 3430 3430
Low Readings 3318 3318
Device Alarm System 2934 2934
Adverse Event Without Identified Device or Use Problem 2154 2154
Failure to Power Up 852 852
Application Program Problem 377 377
Premature Discharge of Battery 221 221
No Audible Alarm 130 130
Failure to Fire 129 129
Material Twisted/Bent 118 118
No Device Output 104 104
Unintended Electrical Shock 87 87
Power Problem 85 85
Difficult to Insert 65 65
Appropriate Term/Code Not Available 65 65
Display or Visual Feedback Problem 53 53
Key or Button Unresponsive/not Working 41 41
Battery Problem 38 38
Insufficient Information 30 30
Activation, Positioning or Separation Problem 28 28
No Display/Image 23 23
Component Missing 20 20
Data Problem 16 16
Failure to Charge 14 14
Break 14 14
Device Damaged Prior to Use 13 13
Packaging Problem 12 12
Therapeutic or Diagnostic Output Failure 11 11
Defective Device 11 11
Compatibility Problem 10 10
Audible Prompt/Feedback Problem 9 9
Use of Device Problem 9 9
Erratic or Intermittent Display 8 8
Computer Software Problem 8 8
No Apparent Adverse Event 8 8
Application Program Freezes, Becomes Nonfunctional 8 8
Crack 8 8
Shipping Damage or Problem 8 8
Output Problem 7 7
No Audible Prompt/Feedback 7 7
Device Sensing Problem 6 6
Charging Problem 6 6
Firing Problem 5 5
Image Display Error/Artifact 5 5
Patient Device Interaction Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 78763 78763
Hypoglycemia 19840 19840
Loss of consciousness 15087 15087
Convulsion/Seizure 5919 5919
Hyperglycemia 3881 3881
Diaphoresis 3878 3878
Dizziness 3224 3224
Shaking/Tremors 2443 2443
Insufficient Information 2330 2330
Fatigue 1802 1802
Confusion/ Disorientation 1379 1379
Skin Infection 1166 1166
Pain 845 845
Skin Inflammation/ Irritation 810 810
Headache 809 809
Nausea 597 597
Vomiting 573 573
Blurred Vision 557 557
No Known Impact Or Consequence To Patient 507 507
Erythema 377 377
Hypersensitivity/Allergic reaction 361 361
Diabetic Ketoacidosis 308 308
Swelling/ Edema 288 288
Muscle Weakness 257 257
Hemorrhage/Bleeding 249 249
Itching Sensation 247 247
Discomfort 228 228
Purulent Discharge 187 187
Polydipsia 164 164
Cognitive Changes 147 147
Malaise 143 143
Tachycardia 138 138
Fall 125 125
Abscess 120 120
Hot Flashes/Flushes 104 104
Bruise/Contusion 104 104
Device Embedded In Tissue or Plaque 101 101
Cramp(s) /Muscle Spasm(s) 78 78
Chills 72 72
Rash 71 71
Dehydration 62 62
Sweating 61 61
Lethargy 57 57
Numbness 52 52
Seizures 49 49
Coma 47 47
Fever 46 46
Electric Shock 45 45
Burning Sensation 42 42
Blister 42 42

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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