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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device integrated continuous glucose monitoring system with sensor containing dexamethasone acetate
Definition An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. The dexamethasone acetate coating is intended to reduce inflammation at the sensor insertion site.
Product CodeSBA
Regulation Number 862.1357
Device Class 2


Premarket Reviews
ManufacturerDecision
SENSEONICS, INCORPORATED
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 17 17
2025 1061 1061

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 652 652
Adverse Event Without Identified Device or Use Problem 179 179
Output Problem 84 84
Premature End-of-Life Indicator 75 75
Communication or Transmission Problem 50 50
Unable to Obtain Readings 26 26
Connection Problem 19 19
Failure to Sense 15 15
Difficult to Remove 11 11
Insufficient Information 7 7
Battery Problem 4 4
Wireless Communication Problem 3 3
Material Separation 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Sensing Problem 2 2
Installation-Related Problem 2 2
No Device Output 2 2
Device Alarm System 1 1
Expiration Date Error 1 1
No Audible Alarm 1 1
Patient Device Interaction Problem 1 1
Failure to Calibrate 1 1
Appropriate Term/Code Not Available 1 1
Overheating of Device 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 825 825
Hypoglycemia 70 70
Skin Infection 43 43
Hyperglycemia 34 34
Insufficient Information 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Skin Inflammation/ Irritation 16 16
Pain 14 14
Swelling/ Edema 12 12
Hemorrhage/Bleeding 10 10
Unspecified Infection 9 9
Discomfort 9 9
Stroke/CVA 8 8
Implant Pain 5 5
Bruise/Contusion 4 4
Diabetic Ketoacidosis 4 4
Heart Failure/Congestive Heart Failure 4 4
Itching Sensation 4 4
Pneumonia 3 3
Rash 3 3
Fever 3 3
Heart Block 2 2
Unspecified Heart Problem 2 2
Chest Pain 2 2
Cellulitis 2 2
Skin Discoloration 2 2
Bone Fracture(s) 2 2
Hypersensitivity/Allergic reaction 2 2
Burn(s) 1 1
Intracranial Hemorrhage 1 1
Numbness 1 1
Burning Sensation 1 1
Vomiting 1 1
Depression 1 1
Diarrhea 1 1
Pyrosis/Heartburn 1 1
Unspecified Kidney or Urinary Problem 1 1
Hemorrhagic Stroke 1 1
Fluid Discharge 1 1
Cataract 1 1
Dizziness 1 1
Anaphylactic Shock 1 1
Anxiety 1 1
Fasciitis 1 1
Nodule 1 1
Blurred Vision 1 1
Convulsion/Seizure 1 1
Nausea 1 1
Pancreatitis 1 1
Loss of consciousness 1 1

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