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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
  1.  DEN230052  Eversense AP CGM System

MDR Year MDR Reports MDR Events
2024 17 17
2025 394 394

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 260 260
Adverse Event Without Identified Device or Use Problem 58 58
Output Problem 28 28
Communication or Transmission Problem 28 28
Unable to Obtain Readings 26 26
Premature End-of-Life Indicator 22 22
Failure to Sense 15 15
Connection Problem 10 10
Difficult to Remove 4 4
Wireless Communication Problem 3 3
No Device Output 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Sensing Problem 2 2
Material Separation 2 2
Insufficient Information 1 1
Device Alarm System 1 1
No Audible Alarm 1 1
Failure to Calibrate 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 327 327
Hypoglycemia 46 46
Skin Infection 15 15
Hyperglycemia 10 10
Discomfort 7 7
Pain 6 6
Insufficient Information 6 6
Hemorrhage/Bleeding 4 4
Unspecified Infection 4 4
Skin Inflammation/ Irritation 4 4
Heart Failure/Congestive Heart Failure 2 2
Rash 2 2
Swelling/ Edema 2 2
Fluid Discharge 1 1
Pulmonary Hypertension 1 1
Pancreatitis 1 1
Kidney Infection 1 1
Anxiety 1 1
Depression 1 1
Numbness 1 1
Itching Sensation 1 1
Nausea 1 1
Vomiting 1 1
Burning Sensation 1 1
Anaphylactic Shock 1 1
Bruise/Contusion 1 1
Stroke/CVA 1 1
Chest Pain 1 1

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