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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 501 501

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Sense 318 318
Imprecision 296 296
Adverse Event Without Identified Device or Use Problem 162 162
Difficult to Remove 126 126
Material Separation 33 33
Premature End-of-Life Indicator 30 30
Device Sensing Problem 23 23
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
Excessive Heating 2 2
Output Problem 2 2
No Audible Prompt/Feedback 2 2
Use of Device Problem 2 2
Failure to Analyze Signal 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
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 545 545
Discomfort 188 188
Hypoglycemia 165 165
Hyperglycemia 51 51
Unspecified Infection 41 41
Pain 33 33
Abscess 18 18
Skin Infection 18 18
Skin Inflammation/ Irritation 16 16
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
Insufficient Information 2 2
Convulsion/Seizure 2 2
Nodule 2 2
Implant Pain 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
Syncope/Fainting 1 1

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