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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
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 4

MDR Year MDR Reports MDR Events
2018 2 2
2019 26 26
2020 18 18
2021 112 112
2022 81 81
2023 80 80
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 113 113
Imprecision 84 84
Unable to Obtain Readings 27 27
Unexpected Shutdown 12 12
No Device Output 11 11
Unintended Application Program Shut Down 9 9
Appropriate Term/Code Not Available 8 8
No Audible Alarm 7 7
Operating System Version or Upgrade Problem 6 6
Defective Alarm 5 5
Detachment of Device or Device Component 4 4
Display or Visual Feedback Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Inappropriate or Unexpected Reset 3 3
Premature End-of-Life Indicator 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Product Quality Problem 2 2
Low Audible Alarm 2 2
Output Problem 2 2
Physical Resistance/Sticking 2 2
Unintended Electrical Shock 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Computer Software Problem 1 1
Overheating of Device 1 1
Retraction Problem 1 1
Shipping Damage or Problem 1 1
Defective Component 1 1
High Test Results 1 1
Low Readings 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Connection Problem 1 1
Loss of Data 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 267 267
No Consequences Or Impact To Patient 33 33
Hypoglycemia 6 6
No Known Impact Or Consequence To Patient 5 5
Hyperglycemia 3 3
Foreign Body In Patient 3 3
Rash 2 2
Loss of consciousness 2 2
Skin Tears 1 1
Confusion/ Disorientation 1 1
Blood Loss 1 1
Pain 1 1
Erythema 1 1
Hemorrhage/Bleeding 1 1
Skin Discoloration 1 1
Dysphasia 1 1
No Code Available 1 1
Convulsion/Seizure 1 1
Insufficient Information 1 1

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