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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 153 153

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 120 120
Unable to Obtain Readings 16 16
Adverse Event Without Identified Device or Use Problem 16 16
Communication or Transmission Problem 10 10
Failure to Sense 10 10
Connection Problem 7 7
Wireless Communication Problem 2 2
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 130 130
Hypoglycemia 24 24
Skin Infection 5 5
Unspecified Infection 4 4
Discomfort 3 3
Hyperglycemia 2 2
Pain 2 2
Itching Sensation 1 1
Burning Sensation 1 1
Swelling/ Edema 1 1
Hemorrhage/Bleeding 1 1

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