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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 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 357 357

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 267 267
Failure to Sense 264 264
Adverse Event Without Identified Device or Use Problem 134 134
Difficult to Remove 114 114
Premature End-of-Life Indicator 30 30
Material Separation 22 22
Device Sensing Problem 18 18
Optical Problem 16 16
Insufficient Information 10 10
Calibration Problem 9 9
No Apparent Adverse Event 9 9
Installation-Related Problem 8 8
Connection Problem 7 7
Improper or Incorrect Procedure or Method 5 5
Device Ingredient or Reagent Problem 4 4
Chemical Problem 4 4
Battery Problem 3 3
Communication or Transmission Problem 3 3
Electrical /Electronic Property Problem 2 2
Use of Device Problem 2 2
Excessive Heating 2 2
Display or Visual Feedback Problem 2 2
Output Problem 2 2
Overheating of Device 2 2
No Audible Prompt/Feedback 2 2
Device Alarm System 1 1
No Device Output 1 1
Failure to Charge 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 463 463
Discomfort 162 162
Hypoglycemia 151 151
Hyperglycemia 45 45
Unspecified Infection 34 34
Pain 24 24
Skin Infection 16 16
Skin Inflammation/ Irritation 10 10
Swelling/ Edema 9 9
Abscess 9 9
Hemorrhage/Bleeding 6 6
Diabetic Ketoacidosis 6 6
Fluid Discharge 5 5
Shaking/Tremors 4 4
Loss of consciousness 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Fever 3 3
Bruise/Contusion 3 3
Muscle Weakness 3 3
Nausea 2 2
Urinary Tract Infection 2 2
Blurred Vision 2 2
Burning Sensation 2 2
Itching Sensation 2 2
Wound Dehiscence 2 2
Abdominal Pain 2 2
Purulent Discharge 2 2
Fatigue 2 2
Hypersensitivity/Allergic reaction 2 2
Implant Pain 2 2
Insufficient Information 2 2
Convulsion/Seizure 2 2
Movement Disorder 2 2
Rash 2 2
Concussion 2 2
Dizziness 1 1
Anaphylactoid 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Hernia 1 1
Anxiety 1 1
Scar Tissue 1 1
Sepsis 1 1
Hip Fracture 1 1
Malaise 1 1
Respiratory Failure 1 1
Impaired Healing 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
Nodule 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
Laceration(s) 1 1
Inflammation 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Failure of Implant 1 1
Chills 1 1
Pneumonia 1 1

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