Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 105 105
No Device Output 89 89
Premature End-of-Life Indicator 12 12
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 221 221
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

-
-