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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
Regulation Description Integrated continuous glucose monitoring system.
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

MDR Year MDR Reports MDR Events
2021 93 93
2022 59 61
2023 62 64
2024 18 20
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 107 110
No Device Output 92 93
Premature End-of-Life Indicator 14 16
Imprecision 7 7
Appropriate Term/Code Not Available 5 5
Adverse Event Without Identified Device or Use Problem 3 3
Break 2 2
Detachment of Device or Device Component 2 2
Unable to Obtain Readings 1 1
Unintended Ejection 1 1
Inappropriate or Unexpected Reset 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 230 236
Foreign Body In Patient 2 2
Skin Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Skin Inflammation/ Irritation 1 1
Erythema 1 1
Insufficient Information 1 1
Pain 1 1
Fluid Discharge 1 1
Swelling/ Edema 1 1
No Consequences Or Impact To Patient 1 1

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