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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)
2017 2018 2019 2020 2021 2022
0 0 2 0 0 2

MDR Year MDR Reports MDR Events
2020 1 1
2022 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 18 18
Failure to Sense 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Difficult to Remove 8 8
Device Sensing Problem 2 2
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
Discomfort 10 10
Hypoglycemia 9 9
Hyperglycemia 4 4
Unspecified Infection 4 4
Diabetic Ketoacidosis 1 1
Constipation 1 1
Failure of Implant 1 1
Abdominal Pain 1 1
Fall 1 1
Gastritis 1 1

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