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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
0 2 0 0 2 0

MDR Year MDR Reports MDR Events
2020 14 14
2021 6 6
2022 166 166

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 51 51
Difficult to Remove 44 44
Failure to Sense 43 43
Adverse Event Without Identified Device or Use Problem 29 29
Device Sensing Problem 11 11
Material Separation 7 7
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 72 72
Discomfort 57 57
Hypoglycemia 30 30
Unspecified Infection 10 10
Hyperglycemia 8 8
Pain 3 3
Abdominal Pain 2 2
Diabetic Ketoacidosis 2 2
Constipation 1 1
Movement Disorder 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Limb Fracture 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
Hip Fracture 1 1
Angina 1 1
Chest Pain 1 1
Fall 1 1
Gastritis 1 1
Sepsis 1 1
Urinary Tract Infection 1 1
Hernia 1 1

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