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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 non-intensive diabetes management
Regulation Description Integrated continuous glucose monitoring system.
Definition An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.
Product CodeQDK
Regulation Number 862.1355
Device Class 2


Premarket Reviews
ManufacturerDecision
DEXCOM, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 111 111
2022 81 83
2023 78 79
2024 238 238
2025 66 66

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 362 362
Imprecision 81 81
No Device Output 40 40
Unable to Obtain Readings 27 29
Unexpected Shutdown 12 12
Appropriate Term/Code Not Available 8 8
Unintended Application Program Shut Down 7 7
Operating System Version or Upgrade Problem 6 6
No Audible Alarm 5 6
Defective Alarm 4 4
Display or Visual Feedback Problem 4 4
Detachment of Device or Device Component 4 4
Premature End-of-Life Indicator 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Product Quality Problem 2 2
Overheating of Device 1 1
Unintended Electrical Shock 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Low Audible Alarm 1 1
Break 1 1
Low Readings 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 563 566
Foreign Body In Patient 3 3
Hyperglycemia 3 3
Hypoglycemia 3 3
Diabetic Ketoacidosis 2 2
Loss of consciousness 2 2
Dysphasia 1 1
Diaphoresis 1 1
Dizziness 1 1
Malaise 1 1
Confusion/ Disorientation 1 1
Rash 1 1
Erythema 1 1
Insufficient Information 1 1
Shaking/Tremors 1 1
Polydipsia 1 1
Skin Tears 1 1
Convulsion/Seizure 1 1
No Consequences Or Impact To Patient 1 1
Urinary Frequency 1 1
Lethargy 1 1

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