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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 39507 39507
2024 32851 32851

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 81967 81967
Unable to Obtain Readings 16900 16900
Device Displays Incorrect Message 16700 16700
Detachment of Device or Device Component 4286 4286
High Readings 4255 4255
Low Readings 3739 3739
Product Quality Problem 3534 3534
Device Alarm System 3109 3109
Adverse Event Without Identified Device or Use Problem 2347 2347
Failure to Power Up 909 909
Application Program Problem 434 434
Premature Discharge of Battery 231 231
Failure to Fire 144 144
No Audible Alarm 130 130
Material Twisted/Bent 128 128
No Device Output 113 113
Power Problem 93 93
Unintended Electrical Shock 91 91
Difficult to Insert 67 67
Appropriate Term/Code Not Available 65 65
Display or Visual Feedback Problem 53 53
Key or Button Unresponsive/not Working 46 46
Battery Problem 38 38
Activation, Positioning or Separation Problem 34 34
Insufficient Information 30 30
No Display/Image 23 23
Component Missing 20 20
Data Problem 16 16
Break 15 15
Failure to Charge 14 14
Device Damaged Prior to Use 14 14
Packaging Problem 12 12
Defective Device 11 11
Therapeutic or Diagnostic Output Failure 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
Application Program Freezes, Becomes Nonfunctional 8 8
No Apparent Adverse Event 8 8
Charging Problem 8 8
Shipping Damage or Problem 8 8
Crack 8 8
No Audible Prompt/Feedback 7 7
Output Problem 7 7
Device Sensing Problem 6 6
Difficult or Delayed Activation 6 6
Patient Device Interaction Problem 5 5
Communication or Transmission Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85399 85399
Hypoglycemia 21420 21420
Loss of consciousness 16188 16188
Convulsion/Seizure 6288 6288
Hyperglycemia 4259 4259
Diaphoresis 4232 4232
Dizziness 3524 3524
Shaking/Tremors 2646 2646
Insufficient Information 2455 2455
Fatigue 2103 2103
Confusion/ Disorientation 1477 1477
Skin Infection 1297 1297
Pain 937 937
Headache 889 889
Skin Inflammation/ Irritation 866 866
Nausea 659 659
Vomiting 648 648
Blurred Vision 623 623
No Known Impact Or Consequence To Patient 507 507
Erythema 416 416
Hypersensitivity/Allergic reaction 388 388
Diabetic Ketoacidosis 343 343
Swelling/ Edema 319 319
Itching Sensation 270 270
Hemorrhage/Bleeding 264 264
Discomfort 258 258
Muscle Weakness 257 257
Purulent Discharge 219 219
Cognitive Changes 194 194
Polydipsia 180 180
Tachycardia 156 156
Malaise 143 143
Abscess 130 130
Fall 126 126
Bruise/Contusion 112 112
Hot Flashes/Flushes 111 111
Device Embedded In Tissue or Plaque 105 105
Rash 79 79
Cramp(s) /Muscle Spasm(s) 78 78
Chills 72 72
Dehydration 67 67
Sweating 61 61
Lethargy 57 57
Fever 56 56
Numbness 55 55
Coma 50 50
Seizures 49 49
Burning Sensation 48 48
Blister 47 47
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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