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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sensor, glucose, implanted, non-adjunctive use
Definition A non-adjunctive implanted glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
Product CodeQHJ
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 3 5 0 1 0

MDR Year MDR Reports MDR Events
2021 9 18
2022 173 200
2023 341 341
2024 915 915
2025 615 615

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 623 630
Failure to Sense 470 478
Adverse Event Without Identified Device or Use Problem 345 346
Difficult to Remove 243 261
Premature End-of-Life Indicator 172 172
Material Separation 83 83
Communication or Transmission Problem 39 39
Connection Problem 30 30
Device Sensing Problem 28 30
No Apparent Adverse Event 16 16
Installation-Related Problem 16 16
Optical Problem 16 16
Insufficient Information 14 14
Calibration Problem 9 9
Battery Problem 8 8
Improper or Incorrect Procedure or Method 6 6
Output Problem 6 6
Chemical Problem 4 4
Device Ingredient or Reagent Problem 4 4
No Device Output 3 3
Display or Visual Feedback Problem 3 3
Failure to Analyze Signal 3 3
Excessive Heating 3 3
Positioning Failure 3 3
Device Alarm System 3 3
Use of Device Problem 2 2
No Audible Prompt/Feedback 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Positioning Problem 2 2
Overheating of Device 2 2
Electrical /Electronic Property Problem 2 2
Unable to Obtain Readings 1 1
No Audible Alarm 1 1
Environmental Compatibility Problem 1 1
Material Deformation 1 1
Expiration Date Error 1 1
Wireless Communication Problem 1 1
Increased Sensitivity 1 1
Unintended Electrical Shock 1 1
Malposition of Device 1 1
Mechanical Problem 1 1
Fire 1 1
Operating System Becomes Nonfunctional 1 1
Failure to Charge 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1228 1241
Discomfort 290 308
Hypoglycemia 239 241
Hyperglycemia 85 87
Skin Infection 68 68
Pain 62 62
Unspecified Infection 61 62
Skin Inflammation/ Irritation 59 59
Abscess 25 25
Hemorrhage/Bleeding 19 19
Swelling/ Edema 15 15
Implant Pain 12 12
Insufficient Information 11 11
Diabetic Ketoacidosis 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Muscle Weakness 7 7
Bruise/Contusion 6 6
Fluid Discharge 5 5
Rash 5 5
Nausea 4 4
Inflammation 4 4
Loss of consciousness 4 4
Shaking/Tremors 4 4
Abdominal Pain 3 3
Impaired Healing 3 3
Pneumonia 3 3
Fatigue 3 3
Dizziness 3 3
Convulsion/Seizure 3 3
Fever 3 3
Unspecified Kidney or Urinary Problem 2 2
Concussion 2 2
Vomiting 2 2
Diarrhea 2 2
Burning Sensation 2 2
Nodule 2 2
Movement Disorder 2 2
Hypoxia 2 2
Blurred Vision 2 2
Itching Sensation 2 2
Purulent Discharge 2 2
Low Blood Pressure/ Hypotension 2 2
Urinary Tract Infection 2 2
Hypersensitivity/Allergic reaction 2 2
Wound Dehiscence 2 2
Syncope/Fainting 2 2
High Blood Pressure/ Hypertension 2 2
Anxiety 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Myocardial Infarction 1 1

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