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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)
2018 2019 2020 2021 2022 2023 2024
0 6 1 0 3 5 0

MDR Year MDR Reports MDR Events
2020 18 18
2021 9 9
2022 173 173
2023 341 341
2024 663 663

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Sense 362 362
Imprecision 328 328
Adverse Event Without Identified Device or Use Problem 209 209
Difficult to Remove 147 147
Material Separation 44 44
Premature End-of-Life Indicator 30 30
Device Sensing Problem 25 25
Optical Problem 16 16
Insufficient Information 11 11
Connection Problem 11 11
No Apparent Adverse Event 10 10
Calibration Problem 9 9
Installation-Related Problem 8 8
Communication or Transmission Problem 8 8
Improper or Incorrect Procedure or Method 6 6
Chemical Problem 4 4
Device Ingredient or Reagent Problem 4 4
Battery Problem 3 3
Positioning Failure 3 3
Failure to Analyze Signal 3 3
Device Alarm System 2 2
Use of Device Problem 2 2
No Audible Prompt/Feedback 2 2
Output Problem 2 2
Excessive Heating 2 2
Overheating of Device 2 2
Electrical /Electronic Property Problem 2 2
Display or Visual Feedback Problem 2 2
Failure to Charge 1 1
Unintended Electrical Shock 1 1
Increased Sensitivity 1 1
Expiration Date Error 1 1
Positioning Problem 1 1
Temperature Problem 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 627 627
Discomfort 223 223
Hypoglycemia 175 175
Hyperglycemia 54 54
Unspecified Infection 50 50
Pain 46 46
Skin Infection 25 25
Abscess 23 23
Skin Inflammation/ Irritation 23 23
Hemorrhage/Bleeding 11 11
Swelling/ Edema 10 10
Bruise/Contusion 6 6
Diabetic Ketoacidosis 6 6
Fluid Discharge 5 5
Muscle Weakness 5 5
Implant Pain 5 5
Shaking/Tremors 4 4
Abdominal Pain 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Nausea 3 3
Rash 3 3
Fever 3 3
Loss of consciousness 3 3
Insufficient Information 2 2
Concussion 2 2
Burning Sensation 2 2
Nodule 2 2
Movement Disorder 2 2
Blurred Vision 2 2
Convulsion/Seizure 2 2
Itching Sensation 2 2
Purulent Discharge 2 2
Inflammation 2 2
Dizziness 2 2
Fatigue 2 2
Hypersensitivity/Allergic reaction 2 2
Wound Dehiscence 2 2
Urinary Tract Infection 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
Muscle/Tendon Damage 1 1
Respiratory Failure 1 1
Neuralgia 1 1
Limb Fracture 1 1
Pneumonia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Senseonics, Inc. II Oct-31-2019
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