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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 6

MDR Year MDR Reports MDR Events
2020 200730 200730
2021 254819 254819
2022 232288 232288
2023 273557 273557
2024 347107 347109
2025 28847 28847

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 596617 596618
No Device Output 256828 256828
Imprecision 82557 82557
Incorrect, Inadequate or Imprecise Result or Readings 76484 76484
Premature End-of-Life Indicator 76151 76151
Detachment of Device or Device Component 48340 48340
Unintended Application Program Shut Down 47370 47371
Communication or Transmission Problem 28895 28895
Appropriate Term/Code Not Available 21303 21303
Device Displays Incorrect Message 15029 15029
Break 12744 12744
Inappropriate or Unexpected Reset 9759 9759
Unable to Obtain Readings 9559 9559
Connection Problem 8851 8851
Unexpected Shutdown 8327 8327
Display or Visual Feedback Problem 7128 7128
No Audible Alarm 6545 6545
Failure to Sense 5681 5681
Defective Alarm 5338 5338
Operating System Version or Upgrade Problem 3536 3536
Adverse Event Without Identified Device or Use Problem 2657 2657
Unintended Ejection 2281 2281
Application Program Freezes, Becomes Nonfunctional 2237 2237
Low Audible Alarm 1076 1076
High Readings 705 705
Overheating of Device 701 701
Low Readings 678 678
Alarm Not Visible 617 617
Delayed Alarm 452 452
Device Alarm System 336 336
Insufficient Information 301 301
Product Quality Problem 209 209
Unintended Electrical Shock 145 145
Application Program Problem 103 103
Failure to Power Up 93 93
Patient-Device Incompatibility 87 87
Output Problem 45 45
Use of Device Problem 43 43
Therapeutic or Diagnostic Output Failure 37 37
Retraction Problem 35 35
Defective Device 31 31
Device Sensing Problem 27 27
Material Twisted/Bent 25 25
Premature Discharge of Battery 22 22
Intermittent Program or Algorithm Execution 22 22
Charging Problem 18 18
Failure to Fire 16 16
Pumping Stopped 13 13
Separation Failure 13 13
Unintended System Motion 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1052182 1052184
No Consequences Or Impact To Patient 143943 143943
Hyperglycemia 68743 68743
No Known Impact Or Consequence To Patient 51639 51639
Hypoglycemia 15199 15199
Loss of consciousness 4498 4498
Foreign Body In Patient 3888 3888
Dizziness 2405 2405
Fatigue 1920 1920
Diaphoresis 1599 1599
Malaise 1584 1584
Erythema 1537 1537
Convulsion/Seizure 1370 1370
Nausea 1369 1369
Polydipsia 1367 1367
Vomiting 1343 1343
Shaking/Tremors 1295 1295
Diabetic Ketoacidosis 1268 1268
Headache 1258 1258
Skin Infection 1185 1185
Confusion/ Disorientation 1137 1137
Skin Inflammation/ Irritation 1123 1123
Rash 1065 1065
Pain 1008 1008
Itching Sensation 974 974
Insufficient Information 821 821
Hemorrhage/Bleeding 690 690
Urinary Frequency 621 621
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 566 566
Lethargy 477 477
Fall 460 460
Swelling/ Edema 430 430
Blister 410 410
Irritability 381 381
Blurred Vision 378 378
Scar Tissue 367 367
Dehydration 366 366
Hypoglycemic Shock 356 356
Abdominal Pain 334 334
Skin Burning Sensation 316 316
Cognitive Changes 308 308
Reaction 308 308
Presyncope 301 301
Purulent Discharge 301 301
Hypersensitivity/Allergic reaction 288 288
Dry Mouth 280 280
Fluid Discharge 272 272
Muscle Weakness 269 269
Discomfort 250 250
Anxiety 217 217

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
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