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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)
2020 2021 2022 2023 2024 2025
1 0 3 5 0 1

MDR Year MDR Reports MDR Events
2020 18 18
2021 9 9
2022 173 173
2023 341 341
2024 915 915
2025 134 134

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Sense 473 473
Imprecision 416 416
Adverse Event Without Identified Device or Use Problem 283 283
Difficult to Remove 197 197
Material Separation 72 72
Premature End-of-Life Indicator 44 44
Connection Problem 28 28
Device Sensing Problem 27 27
Communication or Transmission Problem 19 19
Optical Problem 16 16
No Apparent Adverse Event 14 14
Installation-Related Problem 12 12
Insufficient Information 11 11
Calibration Problem 9 9
Improper or Incorrect Procedure or Method 6 6
Battery Problem 5 5
Chemical Problem 4 4
Device Ingredient or Reagent Problem 4 4
Output Problem 3 3
Failure to Analyze Signal 3 3
Excessive Heating 3 3
Positioning Failure 3 3
No Device Output 2 2
Electrical /Electronic Property Problem 2 2
Display or Visual Feedback Problem 2 2
Overheating of Device 2 2
No Audible Prompt/Feedback 2 2
Use of Device Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Positioning Problem 2 2
Device Alarm System 2 2
Environmental Compatibility Problem 1 1
Material Deformation 1 1
Unable to Obtain Readings 1 1
No Audible Alarm 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
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 864 864
Discomfort 297 297
Hypoglycemia 204 204
Hyperglycemia 63 63
Unspecified Infection 61 61
Pain 55 55
Skin Infection 47 47
Skin Inflammation/ Irritation 44 44
Abscess 25 25
Hemorrhage/Bleeding 16 16
Swelling/ Edema 13 13
Diabetic Ketoacidosis 9 9
Implant Pain 8 8
Muscle Weakness 7 7
Bruise/Contusion 6 6
Fluid Discharge 5 5
Shaking/Tremors 4 4
Loss of consciousness 4 4
Abdominal Pain 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Nausea 3 3
Rash 3 3
Inflammation 3 3
Fever 3 3
Convulsion/Seizure 3 3
Insufficient Information 2 2
Concussion 2 2
Burning Sensation 2 2
Nodule 2 2
Movement Disorder 2 2
Blurred Vision 2 2
Itching Sensation 2 2
Purulent Discharge 2 2
Dizziness 2 2
Fatigue 2 2
Urinary Tract Infection 2 2
Hypersensitivity/Allergic reaction 2 2
Wound Dehiscence 2 2
Syncope/Fainting 2 2
Impaired Healing 2 2
Hypoxia 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Anxiety 1 1
Headache 1 1
Constipation 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Failure 1 1
Muscle/Tendon Damage 1 1
Neuralgia 1 1
Limb Fracture 1 1

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