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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 302 302

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 209 209
Adverse Event Without Identified Device or Use Problem 43 43
Unable to Obtain Readings 26 26
Communication or Transmission Problem 18 18
Failure to Sense 15 15
Output Problem 13 13
Premature End-of-Life Indicator 12 12
Connection Problem 9 9
Wireless Communication Problem 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Separation 2 2
No Device Output 2 2
Device Alarm System 1 1
No Audible Alarm 1 1
Difficult to Remove 1 1
Device Sensing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 252 252
Hypoglycemia 40 40
Skin Infection 13 13
Hyperglycemia 7 7
Unspecified Infection 4 4
Discomfort 4 4
Insufficient Information 4 4
Pain 4 4
Hemorrhage/Bleeding 3 3
Skin Inflammation/ Irritation 2 2
Swelling/ Edema 2 2
Pulmonary Hypertension 1 1
Stroke/CVA 1 1
Pancreatitis 1 1
Nausea 1 1
Itching Sensation 1 1
Burning Sensation 1 1
Chest Pain 1 1
Vomiting 1 1
Numbness 1 1
Fluid Discharge 1 1
Heart Failure/Congestive Heart Failure 1 1
Bruise/Contusion 1 1
Kidney Infection 1 1

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