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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)
2019 2020 2021 2022 2023 2024
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 550 550

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Sense 335 335
Imprecision 303 303
Adverse Event Without Identified Device or Use Problem 174 174
Difficult to Remove 132 132
Material Separation 38 38
Premature End-of-Life Indicator 30 30
Device Sensing Problem 24 24
Optical Problem 16 16
Insufficient Information 11 11
No Apparent Adverse Event 10 10
Connection Problem 9 9
Calibration Problem 9 9
Installation-Related Problem 8 8
Communication or Transmission Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Chemical Problem 4 4
Device Ingredient or Reagent Problem 4 4
Battery Problem 3 3
Failure to Analyze Signal 3 3
Use of Device Problem 2 2
No Audible Prompt/Feedback 2 2
Overheating of Device 2 2
Display or Visual Feedback Problem 2 2
Electrical /Electronic Property Problem 2 2
Excessive Heating 2 2
Output Problem 2 2
Positioning Problem 1 1
Unintended Electrical Shock 1 1
Device Alarm System 1 1
Failure to Charge 1 1
No Device Output 1 1
Expiration Date Error 1 1
Increased Sensitivity 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 571 571
Discomfort 200 200
Hypoglycemia 167 167
Hyperglycemia 52 52
Unspecified Infection 45 45
Pain 36 36
Skin Infection 20 20
Abscess 19 19
Skin Inflammation/ Irritation 18 18
Swelling/ Edema 9 9
Hemorrhage/Bleeding 7 7
Diabetic Ketoacidosis 6 6
Fluid Discharge 5 5
Shaking/Tremors 4 4
Muscle Weakness 4 4
Nausea 3 3
Rash 3 3
Fever 3 3
Bruise/Contusion 3 3
Loss of consciousness 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Implant Pain 2 2
Insufficient Information 2 2
Convulsion/Seizure 2 2
Nodule 2 2
Movement Disorder 2 2
Burning Sensation 2 2
Concussion 2 2
Wound Dehiscence 2 2
Abdominal Pain 2 2
Purulent Discharge 2 2
Fatigue 2 2
Hypersensitivity/Allergic reaction 2 2
Urinary Tract Infection 2 2
Blurred Vision 2 2
Itching Sensation 2 2
Laceration(s) 1 1
Inflammation 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Failure of Implant 1 1
Vomiting 1 1
Scar Tissue 1 1
Sepsis 1 1
Pneumonia 1 1
High Blood Pressure/ Hypertension 1 1
Fall 1 1
Gastritis 1 1
Headache 1 1
Angina 1 1
Asthma 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Diarrhea 1 1
Dizziness 1 1
Anaphylactoid 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Hernia 1 1
Anxiety 1 1
Chills 1 1
Hip Fracture 1 1
Malaise 1 1
Respiratory Failure 1 1
Impaired Healing 1 1
Coma 1 1
Electric Shock 1 1
Lethargy 1 1
Constipation 1 1
Neuralgia 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Limb Fracture 1 1
Muscle/Tendon Damage 1 1
Easy Bruising 1 1
Syncope/Fainting 1 1

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