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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 Reviews
ManufacturerDecision
SENSEONICS, INCORPORATED
  GRANTED 1

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 423 423

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Sense 287 287
Imprecision 278 278
Adverse Event Without Identified Device or Use Problem 147 147
Difficult to Remove 122 122
Premature End-of-Life Indicator 30 30
Material Separation 23 23
Device Sensing Problem 23 23
Optical Problem 16 16
Insufficient Information 11 11
No Apparent Adverse Event 10 10
Calibration Problem 9 9
Connection Problem 9 9
Installation-Related Problem 8 8
Improper or Incorrect Procedure or Method 5 5
Device Ingredient or Reagent Problem 4 4
Chemical Problem 4 4
Communication or Transmission Problem 4 4
Battery Problem 3 3
Excessive Heating 2 2
Output Problem 2 2
No Audible Prompt/Feedback 2 2
Use of Device Problem 2 2
Overheating of Device 2 2
Display or Visual Feedback Problem 2 2
Electrical /Electronic Property Problem 2 2
Device Alarm System 1 1
Failure to Charge 1 1
No Device Output 1 1
Failure to Analyze Signal 1 1
Expiration Date Error 1 1
Increased Sensitivity 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 502 502
Discomfort 173 173
Hypoglycemia 158 158
Hyperglycemia 46 46
Unspecified Infection 40 40
Pain 32 32
Skin Infection 16 16
Abscess 15 15
Skin Inflammation/ Irritation 14 14
Swelling/ Edema 9 9
Hemorrhage/Bleeding 6 6
Diabetic Ketoacidosis 6 6
Fluid Discharge 5 5
Shaking/Tremors 4 4
Rash 3 3
Fever 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Loss of consciousness 3 3
Bruise/Contusion 3 3
Muscle Weakness 3 3
Concussion 2 2
Fatigue 2 2
Burning Sensation 2 2
Implant Pain 2 2
Nausea 2 2
Movement Disorder 2 2
Abdominal Pain 2 2
Convulsion/Seizure 2 2
Urinary Tract Infection 2 2
Blurred Vision 2 2
Hypersensitivity/Allergic reaction 2 2
Insufficient Information 2 2
Wound Dehiscence 2 2
Purulent Discharge 2 2
Itching Sensation 2 2
Headache 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Asthma 1 1
Nodule 1 1
Dizziness 1 1
Chest Pain 1 1
Diarrhea 1 1
Pneumonia 1 1
Hernia 1 1
High Blood Pressure/ Hypertension 1 1
Fall 1 1
Low Blood Pressure/ Hypotension 1 1
Neuralgia 1 1
Anaphylactoid 1 1
Respiratory Failure 1 1
Hypoxia 1 1
Electric Shock 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Malaise 1 1
Chills 1 1
Inflammation 1 1
Constipation 1 1
Stroke/CVA 1 1
Scar Tissue 1 1
Laceration(s) 1 1
Impaired Healing 1 1
Anxiety 1 1
Angina 1 1
Limb Fracture 1 1
Gastritis 1 1
Sepsis 1 1
Muscle/Tendon Damage 1 1
Lethargy 1 1
Hip Fracture 1 1
Failure of Implant 1 1

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