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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, factory calibrated
Regulation Description Integrated continuous glucose monitoring system.
Definition An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.
Product CodeQBJ
Regulation Number 862.1355
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT DIABETES CARE INC.
  SUBSTANTIALLY EQUIVALENT 3
DEXCOM INC.
  SUBSTANTIALLY EQUIVALENT 2
DEXCOM, INC.
  SUBSTANTIALLY EQUIVALENT 7
  1.  K200876  Dexcom G6 Continuous Glucose Monitoring System, De ...
  2.  K201328  Dexcom G6 Continuous Glucose Monitoring (CGM) Syst ...
  3.  K213919  Dexcom G7 Continuous Glucose Monitoring System
  4.  K221259  Dexcom G6 Continuous Glucose Monitoring (CGM) Syst ...
  5.  K223931  Dexcom G6 Continuous Glucose Monitoring (CGM) Syst ...
  6.  K231081  Dexcom G7 Continuous Glucose Monitoring (CGM) Syst ...
  7.  K243214  Dexcom G7 15 Day Continuous Glucose Monitoring Sys ...

MDR Year MDR Reports MDR Events
2020 200730 200730
2021 254820 254820
2022 232288 232288
2023 273560 273560
2024 347114 347115
2025 139833 139833

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 625523 625523
No Device Output 263340 263340
Incorrect, Inadequate or Imprecise Result or Readings 97827 97827
Premature End-of-Life Indicator 82931 82931
Imprecision 82558 82558
Detachment of Device or Device Component 76347 76347
Unintended Application Program Shut Down 51646 51647
Communication or Transmission Problem 28940 28940
Appropriate Term/Code Not Available 23134 23134
Break 16022 16022
Device Displays Incorrect Message 15267 15267
Inappropriate or Unexpected Reset 12218 12218
Unable to Obtain Readings 10113 10113
Unexpected Shutdown 9836 9836
Connection Problem 8933 8933
Display or Visual Feedback Problem 8297 8297
No Audible Alarm 7524 7524
Defective Alarm 6296 6296
Failure to Sense 5687 5687
Operating System Version or Upgrade Problem 3953 3953
Adverse Event Without Identified Device or Use Problem 3017 3017
Application Program Freezes, Becomes Nonfunctional 2677 2677
Unintended Ejection 2578 2578
Low Audible Alarm 1273 1273
Low Readings 1235 1235
High Readings 847 847
Overheating of Device 760 760
Alarm Not Visible 647 647
Delayed Alarm 455 455
Device Alarm System 395 395
Product Quality Problem 314 314
Insufficient Information 310 310
Unintended Electrical Shock 166 166
Application Program Problem 141 141
Therapeutic or Diagnostic Output Failure 117 117
Failure to Power Up 105 105
Defective Device 100 100
Patient-Device Incompatibility 90 90
Device Sensing Problem 87 87
Output Problem 51 51
Use of Device Problem 49 49
Activation, Positioning or Separation Problem 37 37
Retraction Problem 36 36
Material Twisted/Bent 27 27
Premature Discharge of Battery 26 26
Difficult to Insert 22 22
Intermittent Program or Algorithm Execution 22 22
Failure to Fire 20 20
Computer Software Problem 20 20
Difficult to Open or Remove Packaging Material 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1145458 1145459
No Consequences Or Impact To Patient 143943 143943
Hyperglycemia 81786 81786
No Known Impact Or Consequence To Patient 51639 51639
Hypoglycemia 17847 17847
Loss of consciousness 5295 5295
Foreign Body In Patient 4628 4628
Dizziness 2853 2853
Fatigue 2270 2270
Malaise 1864 1864
Diaphoresis 1820 1820
Erythema 1748 1748
Nausea 1735 1735
Vomiting 1702 1702
Polydipsia 1650 1650
Convulsion/Seizure 1593 1593
Diabetic Ketoacidosis 1554 1554
Headache 1550 1550
Shaking/Tremors 1540 1540
Skin Infection 1400 1400
Confusion/ Disorientation 1376 1376
Skin Inflammation/ Irritation 1332 1332
Pain 1247 1247
Rash 1176 1176
Itching Sensation 1060 1060
Insufficient Information 1052 1052
Hemorrhage/Bleeding 800 800
Urinary Frequency 788 788
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 785 785
Lethargy 559 559
Hypoglycemic Shock 555 555
Swelling/ Edema 537 537
Fall 519 519
Dehydration 509 509
Blurred Vision 460 460
Blister 433 433
Irritability 430 430
Abdominal Pain 400 400
Scar Tissue 390 390
Skin Burning Sensation 355 355
Presyncope 353 353
Cognitive Changes 351 351
Dry Mouth 350 350
Purulent Discharge 348 348
Muscle Weakness 317 317
Hypersensitivity/Allergic reaction 313 313
Reaction 308 308
Discomfort 296 296
Fluid Discharge 294 294
Anxiety 262 262

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health Inc. II Jun-23-2021
2 Dexcom Inc II Mar-25-2020
3 Dexcom Inc II Mar-02-2020
4 Dexcom, Inc. I Jun-16-2025
5 Dexcom, Inc. II Jun-04-2025
6 Dexcom, Inc. II Feb-20-2025
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