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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

MDR Year MDR Reports MDR Events
2020 200730 200730
2021 254820 254820
2022 232288 232288
2023 273558 273558
2024 347114 347115
2025 107182 107182

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 617365 617365
No Device Output 261797 261797
Incorrect, Inadequate or Imprecise Result or Readings 91183 91183
Imprecision 82558 82558
Premature End-of-Life Indicator 81559 81559
Detachment of Device or Device Component 66464 66464
Unintended Application Program Shut Down 50742 50743
Communication or Transmission Problem 28923 28923
Appropriate Term/Code Not Available 22637 22637
Device Displays Incorrect Message 15195 15195
Break 15089 15089
Inappropriate or Unexpected Reset 11543 11543
Unable to Obtain Readings 9927 9927
Unexpected Shutdown 9371 9371
Connection Problem 8910 8910
Display or Visual Feedback Problem 7954 7954
No Audible Alarm 7307 7307
Defective Alarm 6052 6052
Failure to Sense 5681 5681
Operating System Version or Upgrade Problem 3853 3853
Adverse Event Without Identified Device or Use Problem 2932 2932
Application Program Freezes, Becomes Nonfunctional 2572 2572
Unintended Ejection 2510 2510
Low Audible Alarm 1227 1227
Low Readings 1076 1076
High Readings 810 810
Overheating of Device 745 745
Alarm Not Visible 647 647
Delayed Alarm 454 454
Device Alarm System 379 379
Insufficient Information 308 308
Product Quality Problem 257 257
Unintended Electrical Shock 159 159
Application Program Problem 124 124
Failure to Power Up 102 102
Patient-Device Incompatibility 87 87
Therapeutic or Diagnostic Output Failure 66 66
Defective Device 54 54
Device Sensing Problem 53 53
Output Problem 50 50
Use of Device Problem 43 43
Retraction Problem 36 36
Material Twisted/Bent 26 26
Premature Discharge of Battery 24 24
Intermittent Program or Algorithm Execution 22 22
Failure to Fire 19 19
Difficult to Open or Remove Packaging Material 19 19
Charging Problem 18 18
Separation Failure 13 13
Failure to Calibrate 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1118369 1118370
No Consequences Or Impact To Patient 143943 143943
Hyperglycemia 77680 77680
No Known Impact Or Consequence To Patient 51639 51639
Hypoglycemia 17078 17078
Loss of consciousness 5059 5059
Foreign Body In Patient 4321 4321
Dizziness 2712 2712
Fatigue 2163 2163
Malaise 1789 1789
Diaphoresis 1746 1746
Erythema 1694 1694
Nausea 1625 1625
Vomiting 1593 1593
Polydipsia 1552 1552
Convulsion/Seizure 1530 1530
Diabetic Ketoacidosis 1473 1473
Shaking/Tremors 1468 1468
Headache 1445 1445
Skin Infection 1345 1345
Confusion/ Disorientation 1308 1308
Skin Inflammation/ Irritation 1282 1282
Pain 1199 1199
Rash 1151 1151
Itching Sensation 1042 1042
Insufficient Information 951 951
Hemorrhage/Bleeding 762 762
Urinary Frequency 736 736
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 708 708
Lethargy 532 532
Hypoglycemic Shock 502 502
Swelling/ Edema 500 500
Fall 491 491
Dehydration 467 467
Blurred Vision 434 434
Blister 429 429
Irritability 413 413
Scar Tissue 386 386
Abdominal Pain 378 378
Skin Burning Sensation 346 346
Cognitive Changes 340 340
Presyncope 339 339
Purulent Discharge 337 337
Dry Mouth 326 326
Hypersensitivity/Allergic reaction 310 310
Reaction 308 308
Muscle Weakness 307 307
Fluid Discharge 289 289
Discomfort 283 283
Anxiety 246 246

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. II Feb-20-2025
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