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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 1173 1173
2026 287 287

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 874 874
Adverse Event Without Identified Device or Use Problem 251 251
Output Problem 154 154
Communication or Transmission Problem 77 77
Premature End-of-Life Indicator 73 73
Unable to Obtain Readings 26 26
Connection Problem 22 22
Difficult to Remove 17 17
Failure to Sense 13 13
Material Separation 11 11
Insufficient Information 9 9
Battery Problem 6 6
Wireless Communication Problem 3 3
Overheating of Device 3 3
No Device Output 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Calibration Problem 2 2
Environmental Compatibility Problem 2 2
Device Sensing Problem 2 2
Installation-Related Problem 2 2
Device Alarm System 1 1
Expiration Date Error 1 1
No Audible Alarm 1 1
Patient Device Interaction Problem 1 1
Component Missing 1 1
Failure to Calibrate 1 1
Appropriate Term/Code Not Available 1 1
Excessive Heating 1 1
Electrical /Electronic Property Problem 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 1128 1128
Hypoglycemia 79 79
Skin Infection 60 60
Hyperglycemia 59 59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Insufficient Information 27 27
Skin Inflammation/ Irritation 19 19
Swelling/ Edema 18 18
Pain 15 15
Hemorrhage/Bleeding 14 14
Unspecified Infection 10 10
Stroke/CVA 9 9
Discomfort 9 9
Itching Sensation 8 8
Implant Pain 7 7
Diabetic Ketoacidosis 6 6
Pneumonia 6 6
Bruise/Contusion 5 5
Heart Failure/Congestive Heart Failure 5 5
Rash 5 5
Unspecified Heart Problem 3 3
Bone Fracture(s) 3 3
Chest Pain 3 3
Fever 3 3
Urinary Tract Infection 2 2
Cancer 2 2
Heart Block 2 2
Convulsion/Seizure 2 2
Vomiting 2 2
Cellulitis 2 2
Skin Discoloration 2 2
Hypersensitivity/Allergic reaction 2 2
Burn(s) 1 1
Numbness 1 1
Intracranial Hemorrhage 1 1
Burning Sensation 1 1
Depression 1 1
Diarrhea 1 1
Purulent Discharge 1 1
Unspecified Kidney or Urinary Problem 1 1
Urethral Stenosis/Stricture 1 1
Pyrosis/Heartburn 1 1
Fluid Discharge 1 1
Hemorrhagic Stroke 1 1
Cataract 1 1
Anaphylactic Shock 1 1
Anxiety 1 1
Fasciitis 1 1
Nodule 1 1
Undesired Nerve Stimulation 1 1

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