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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 10

MDR Year MDR Reports MDR Events
2021 254833 254878
2022 232288 232381
2023 273566 273750
2024 347115 347156
2025 379881 379882
2026 107005 107005

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 637190 637197
No Device Output 216780 216785
Incorrect, Inadequate or Imprecise Result or Readings 124410 124539
Detachment of Device or Device Component 118919 118946
Premature End-of-Life Indicator 87681 87681
Unintended Application Program Shut Down 61628 61630
Imprecision 58050 58050
Protective Measures Problem 58004 58010
Low Readings 43084 43106
Communication or Transmission Problem 23974 23991
Break 22654 22662
Appropriate Term/Code Not Available 21150 21150
Inappropriate or Unexpected Reset 17320 17320
No Audible Alarm 13934 13935
Unexpected Shutdown 13182 13188
Defective Alarm 12333 12333
Unable to Obtain Readings 10845 10892
High Readings 10215 10233
Display or Visual Feedback Problem 10008 10011
Connection Problem 7699 7699
Operating System Version or Upgrade Problem 7697 7698
Adverse Event Without Identified Device or Use Problem 3785 3808
Device Displays Incorrect Message 3541 3583
Application Program Freezes, Becomes Nonfunctional 3376 3376
Failure to Sense 3247 3251
Unintended Ejection 2878 2878
Low Audible Alarm 2209 2209
Overheating of Device 874 874
Product Quality Problem 765 781
Device Alarm System 678 693
Defective Device 611 623
Alarm Not Visible 486 486
Delayed Alarm 458 458
Device Sensing Problem 431 437
Therapeutic or Diagnostic Output Failure 375 384
Insufficient Information 335 335
Nonstandard Device 266 269
Unintended Electrical Shock 220 222
Application Program Problem 212 215
Failure to Power Up 119 120
Material Twisted/Bent 101 101
Activation, Positioning or Separation Problem 93 98
Output Problem 88 90
No Apparent Adverse Event 79 79
Loss of or Failure to Bond 75 84
Defective Component 69 69
Patient-Device Incompatibility 58 72
Activation Failure 56 56
Difficult to Insert 50 50
False Alarm 48 48

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1421201 1421348
Hyperglycemia 121229 121246
Hypoglycemia 26644 26727
Foreign Body In Patient 8158 8159
Loss of consciousness 7577 7629
Dizziness 4118 4139
No Known Impact Or Consequence To Patient 3760 3760
Fatigue 3237 3240
No Consequences Or Impact To Patient 2893 2893
Vomiting 2821 2822
Nausea 2750 2754
Diaphoresis 2616 2623
Diabetic Ketoacidosis 2552 2559
Malaise 2500 2500
Polydipsia 2362 2363
Convulsion/Seizure 2265 2289
Headache 2263 2267
Erythema 2254 2257
Shaking/Tremors 2168 2173
Insufficient Information 2113 2151
Skin Infection 2063 2072
Confusion/ Disorientation 2026 2036
Pain 1900 1911
Skin Inflammation/ Irritation 1860 1873
Rash 1339 1351
Urinary Frequency 1234 1234
Hypoglycemic Shock 1199 1199
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1193 1193
Itching Sensation 1189 1195
Hemorrhage/Bleeding 1128 1138
Swelling/ Edema 888 891
Lethargy 770 770
Dehydration 755 755
Blurred Vision 745 746
Fall 664 664
Abdominal Pain 578 578
Irritability 543 543
Blister 523 523
Presyncope 507 507
Dry Mouth 495 495
Discomfort 463 463
Muscle Weakness 457 457
Cognitive Changes 454 461
Skin Burning Sensation 450 452
Purulent Discharge 444 446
Scar Tissue 416 417
Hypersensitivity/Allergic reaction 415 420
Anxiety 394 394
Bruise/Contusion 391 392
Dyspnea 369 369

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