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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 11

MDR Year MDR Reports MDR Events
2021 254833 254878
2022 232288 232381
2023 273568 273752
2024 347124 347165
2025 379888 379889
2026 317168 317173

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 670441 670449
No Device Output 219968 219973
Incorrect, Inadequate or Imprecise Result or Readings 156645 156744
Low Readings 148491 148509
Detachment of Device or Device Component 124061 124081
Premature End-of-Life Indicator 88681 88681
Unintended Application Program Shut Down 66044 66046
Protective Measures Problem 58859 58859
Imprecision 57830 57830
Appropriate Device Problem Term/Code Not Available 26376 26376
Break 23825 23825
Communication or Transmission Problem 23822 23825
Inappropriate or Unexpected Reset 19597 19597
No Audible Alarm 15437 15438
Unexpected Shutdown 14775 14778
High Readings 14585 14600
Defective Alarm 13540 13540
Unable to Obtain Readings 12024 12068
Display or Visual Feedback Problem 10833 10836
Operating System Version or Upgrade Problem 8627 8628
Connection Problem 7784 7784
Adverse Event Without Identified Device or Use Problem 4668 4690
Device Displays Incorrect Message 4281 4323
Application Program Freezes or Fails to Launch 3773 3773
Failure to Sense 3230 3230
Unintended Ejection 2996 2996
Low Audible Alarm 2465 2465
Overheating of Device 955 955
Device Alarm System 836 849
Product Quality Problem 739 740
Alarm Not Visible 486 486
Delayed Alarm 456 456
Defective Device 413 413
Insufficient Device Problem Information 331 331
Unintended Electrical Shock 250 252
Therapeutic or Diagnostic Output Failure 238 238
Application Program Problem 217 220
Device Sensing Problem 176 176
Nonstandard Device 169 169
Activation, Positioning or Separation Problem 160 160
Failure to Power Up 142 143
Material Twisted/Bent 103 103
No Apparent Adverse Event 100 100
Output Problem 79 79
Activation Failure 60 60
Failure to Fire 58 58
Loss of or Failure to Bond 54 54
Delivered as Unsterile Product 49 49
False Alarm 47 47
Defective Component 47 47

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1607824 1607973
Hyperglycemia 136354 136371
Hypoglycemia 31113 31197
Foreign Body In Patient 9184 9185
Loss of consciousness 8772 8824
Dizziness 4891 4912
Fatigue 3820 3824
No Known Impact Or Consequence To Patient 3760 3760
Vomiting 3368 3370
Nausea 3257 3261
Diaphoresis 3153 3161
Elevated ketones/Diabetic Ketoacidosis 3069 3076
No Consequences Or Impact To Patient 2893 2893
Malaise 2862 2862
Insufficient Information 2812 2851
Shaking/Tremors 2675 2680
Erythema 2675 2679
Polydipsia 2653 2654
Headache 2618 2622
Convulsion/Seizure 2595 2619
Skin Infection 2484 2493
Pain 2429 2440
Confusion/ Disorientation 2423 2433
Skin Inflammation/ Irritation 2374 2388
Rash 1560 1573
Urinary Frequency / Polyuria 1423 1423
Hemorrhage/Blood Loss/Bleeding 1408 1418
Itching Sensation 1383 1389
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1330 1330
Hypoglycemic Shock 1307 1307
Swelling/ Edema 1126 1129
Blurred Vision 958 959
Dehydration 887 887
Lethargy 871 871
Fall 766 766
Discomfort 677 677
Abdominal Pain 659 659
Presyncope 582 582
Irritability 581 581
Foreign Body Reaction 573 573
Purulent Discharge 563 565
Blister 560 560
Dry Mouth 552 552
Cognitive Changes 532 539
Muscle Weakness/Atrophy 511 511
Hypersensitivity/Allergic reaction 496 501
Anxiety 464 464
Bruise/Contusion 460 461
Skin Burning Sensation 453 455
Scar Tissue 435 436

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health Inc. II Jun-23-2021
2 Dexcom, Inc. II Jun-24-2026
3 Dexcom, Inc. II May-11-2026
4 Dexcom, Inc. I Oct-30-2025
5 Dexcom, Inc. I Sep-04-2025
6 Dexcom, Inc. I Jun-16-2025
7 Dexcom, Inc. II Jun-04-2025
8 Dexcom, Inc. II Feb-20-2025
9 GET TESTED INTERNATIONAL AB II Dec-01-2025
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