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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device continuous glucose monitor, implanted, adjunctive use
Definition The device is a fully implanted continuous glucose monitoring device intended to detect trends and track patterns in interstitial glucose values. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.
Product CodeQCD
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 1 2 0 0

MDR Year MDR Reports MDR Events
2021 157 157
2022 29 29
2023 115 115
2024 364 364

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 306 306
Adverse Event Without Identified Device or Use Problem 204 204
Failure to Sense 69 69
Difficult to Remove 22 22
Insufficient Information 10 10
Overheating of Device 9 9
Device Sensing Problem 8 8
Material Separation 7 7
Electrical /Electronic Property Problem 7 7
Connection Problem 5 5
Calibration Problem 4 4
Device Appears to Trigger Rejection 3 3
Communication or Transmission Problem 2 2
Device Alarm System 2 2
Appropriate Term/Code Not Available 2 2
Activation, Positioning or Separation Problem 1 1
Output Problem 1 1
Device Fell 1 1
Battery Problem 1 1
Use of Device Problem 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Excessive Heating 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypoglycemia 224 224
No Clinical Signs, Symptoms or Conditions 150 150
Hyperglycemia 80 80
Skin Infection 62 62
Discomfort 50 50
Unspecified Infection 31 31
Abscess 30 30
Pain 26 26
Skin Inflammation/ Irritation 23 23
Swelling/ Edema 17 17
Hemorrhage/Bleeding 9 9
Fluid Discharge 9 9
Inflammation 8 8
Implant Pain 6 6
Dizziness 5 5
Nausea 5 5
Itching Sensation 4 4
Insufficient Information 4 4
Diabetic Ketoacidosis 3 3
Numbness 3 3
Bone Fracture(s) 2 2
Hematoma 2 2
Easy Bruising 2 2
Myalgia 1 1
Neurogenic Shock 1 1
Subcutaneous Nodule 1 1
Nodule 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypoglycemic Shock 1 1
Wound Dehiscence 1 1
Headache 1 1
Bacterial Infection 1 1
Stroke/CVA 1 1
Erythema 1 1
Fever 1 1
Laceration(s) 1 1
Undesired Nerve Stimulation 1 1
Hypersensitivity/Allergic reaction 1 1
Loss of consciousness 1 1
Shaking/Tremors 1 1
Lethargy 1 1
Fibrosis 1 1
Convulsion/Seizure 1 1
Hemorrhagic Stroke 1 1
Vertebral Fracture 1 1
Angioedema 1 1
Blister 1 1
Pneumonia 1 1
Rash 1 1
Scar Tissue 1 1

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