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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
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 8

MDR Year MDR Reports MDR Events
2019 80773 80773
2020 200730 200730
2021 254819 254819
2022 232287 232287
2023 273548 273548
2024 131371 131371

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 536306 536306
No Device Output 247013 247013
Imprecision 96469 96469
Premature End-of-Life Indicator 66053 66053
Incorrect, Inadequate or Imprecise Result or Readings 40755 40755
Unintended Application Program Shut Down 30843 30843
Communication or Transmission Problem 30294 30294
Detachment of Device or Device Component 25624 25624
Appropriate Term/Code Not Available 18263 18263
Device Displays Incorrect Message 16073 16073
Connection Problem 9208 9208
Unable to Obtain Readings 8516 8516
Break 7161 7161
Failure to Sense 6431 6431
Inappropriate or Unexpected Reset 5543 5543
Unexpected Shutdown 5511 5511
No Audible Alarm 5154 5154
Defective Alarm 4911 4911
Display or Visual Feedback Problem 4199 4199
Operating System Version or Upgrade Problem 2269 2269
Adverse Event Without Identified Device or Use Problem 2121 2121
Unintended Ejection 1609 1609
Low Audible Alarm 785 785
Alarm Not Visible 746 746
Application Program Freezes, Becomes Nonfunctional 596 596
Overheating of Device 594 594
Retraction Problem 537 537
Insufficient Information 310 310
High Readings 227 227
Low Readings 197 197
Device Alarm System 180 180
Unintended Electrical Shock 140 140
Product Quality Problem 116 116
Patient-Device Incompatibility 87 87
Application Program Problem 78 78
Output Problem 65 65
Use of Device Problem 48 48
Therapeutic or Diagnostic Output Failure 44 44
Failure to Power Up 38 38
Defective Device 32 32
Device Sensing Problem 27 27
Intermittent Program or Algorithm Execution 22 22
Charging Problem 19 19
Pumping Stopped 17 17
Premature Discharge of Battery 16 16
Separation Failure 15 15
Unintended System Motion 13 13
Incorrect Measurement 12 12
Defective Component 12 12
Patient Device Interaction Problem 12 12
Physical Resistance/Sticking 11 11
High Capture Threshold 11 11
Loss of or Failure to Bond 11 11
Electrical /Electronic Property Problem 11 11
Arcing at Paddles 10 10
Difficult to Remove 10 10
Difficult to Open or Remove Packaging Material 10 10
Calibration Problem 9 9
Activation, Positioning or Separation Problem 9 9
Failure to Calibrate 9 9
False Alarm 9 9
Entrapment of Device 8 8
Mechanical Problem 8 8
Nonstandard Device 8 8
Output above Specifications 7 7
Delayed Alarm 7 7
Computer Operating System Problem 7 7
Battery Problem 7 7
Material Twisted/Bent 7 7
Data Problem 7 7
Device Markings/Labelling Problem 6 6
Loss of Data 6 6
Failure to Fire 5 5
Improper or Incorrect Procedure or Method 5 5
Accessory Incompatible 5 5
Computer Software Problem 5 5
Difficult to Insert 5 5
Leak/Splash 5 5
Power Problem 5 5
Key or Button Unresponsive/not Working 5 5
Protective Measures Problem 4 4
Image Display Error/Artifact 4 4
Device Slipped 4 4
Solder Joint Fracture 4 4
Inaccurate Delivery 4 4
Inaudible or Unclear Audible Prompt/Feedback 4 4
Date/Time-Related Software Problem 4 4
Low Test Results 4 4
Obstruction of Flow 4 4
Moisture or Humidity Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Compatibility Problem 3 3
Mechanical Jam 3 3
Device-Device Incompatibility 3 3
Inadequate User Interface 3 3
Device Ingredient or Reagent Problem 3 3
Chemical Problem 3 3
Failure to Read Input Signal 3 3
Expiration Date Error 3 3
Display Difficult to Read 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 840545 840545
No Consequences Or Impact To Patient 208558 208558
No Known Impact Or Consequence To Patient 66891 66891
Hyperglycemia 43888 43888
Hypoglycemia 11150 11150
Loss of consciousness 3073 3073
Foreign Body In Patient 3033 3033
Dizziness 1643 1643
Fatigue 1329 1329
Erythema 1182 1182
Malaise 1123 1123
Diaphoresis 1049 1049
Convulsion/Seizure 913 913
Shaking/Tremors 898 898
Nausea 897 897
Polydipsia 871 871
Headache 860 860
Rash 821 821
Vomiting 817 817
Diabetic Ketoacidosis 816 816
Confusion/ Disorientation 794 794
Itching Sensation 779 779
Skin Inflammation/ Irritation 745 745
Skin Infection 681 681
Pain 679 679
Reaction 477 477
Insufficient Information 429 429
Hemorrhage/Bleeding 420 420
Urinary Frequency 369 369
Fall 364 364
Blister 317 317
Lethargy 316 316
Scar Tissue 299 299
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 282 282
Irritability 275 275
Purulent Discharge 257 257
Swelling/ Edema 249 249
Dehydration 246 246
Abdominal Pain 226 226
Blurred Vision 224 224
Fluid Discharge 213 213
Cognitive Changes 210 210
Skin Burning Sensation 200 200
Hypoglycemic Shock 200 200
Presyncope 192 192
Hypersensitivity/Allergic reaction 183 183
Muscle Weakness 182 182
Discomfort 171 171
Dry Mouth 170 170
Anxiety 156 156
Burning Sensation 154 154
Bruise/Contusion 146 146
Dyspnea 139 139
Abscess 128 128
Scarring 126 126
Unspecified Infection 106 106
Syncope/Fainting 102 102
Coma 100 100
Tachycardia 98 98
Skin Irritation 96 96
Seizures 91 91
Ambulation Difficulties 89 89
Blood Loss 86 86
Fever 73 73
Hot Flashes/Flushes 73 73
Laceration(s) 72 72
Eczema 71 71
Cellulitis 70 70
Swelling 67 67
Inflammation 66 66
Increased Appetite 66 66
Head Injury 64 64
Chest Pain 63 63
Cramp(s) /Muscle Spasm(s) 63 63
Dysphasia 60 60
Pallor 59 59
Burn(s) 58 58
Numbness 58 58
Foreign Body Reaction 53 53
Balance Problems 49 49
Bone Fracture(s) 48 48
Diarrhea 46 46
Bacterial Infection 42 42
Caustic/Chemical Burns 42 42
Skin Discoloration 40 40
Skin Inflammation 38 38
Sweating 34 34
Visual Disturbances 34 34
Peeling 34 34
Aphonia 33 33
Memory Loss/Impairment 32 32
Decreased Appetite 32 32
Emotional Changes 31 31
Urinary Retention 31 31
Abrasion 29 29
High Blood Pressure/ Hypertension 25 25
Arrhythmia 24 24
Myalgia 23 23
Weakness 21 21
Urticaria 20 20

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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