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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 for professional directed retrospective or real-time use
Definition An integrated continuous glucose monitoring system for professional directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.
Product CodeQII
Regulation Number 862.1355
Device Class 2


Premarket Reviews
ManufacturerDecision
DEXCOM, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 93 93
2022 59 59
2023 62 62
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 106 106
No Device Output 91 91
Premature End-of-Life Indicator 14 14
Imprecision 7 7
Appropriate Term/Code Not Available 5 5
Adverse Event Without Identified Device or Use Problem 3 3
Break 3 3
Detachment of Device or Device Component 2 2
Battery Problem: Low Impedance 1 1
Unintended Ejection 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 226 226
Foreign Body In Patient 3 3
Pain 2 2
No Consequences Or Impact To Patient 2 2
Fluid Discharge 1 1
Erythema 1 1
No Known Impact Or Consequence To Patient 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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