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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sensor, glucose, invasive, non-adjunctive
Definition A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
Product CodePQF
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
3 2 1 0 0 0

MDR Year MDR Reports MDR Events
2017 65176 65176
2018 116239 116239
2019 44509 44509
2020 10579 10579
2021 4946 4946
2022 1079 1079

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 90562 90562
Imprecision 51349 51349
Device Displays Incorrect Message 28079 28079
No Device Output 25071 25071
Use of Device Problem 24233 24233
Invalid Sensing 6720 6720
Premature End-of-Life Indicator 4963 4963
Unable to Obtain Readings 4079 4079
Defective Alarm 4066 4066
Device Inoperable 3759 3759
Inappropriate or Unexpected Reset 3401 3401
Detachment of Device or Device Component 2961 2961
Unexpected Shutdown 2848 2848
Device Operates Differently Than Expected 2208 2208
Low Battery 1878 1878
Connection Problem 1584 1584
Component Missing 1319 1319
Unintended Application Program Shut Down 1305 1305
Appropriate Term/Code Not Available 1098 1098
No Audible Alarm 1082 1082
Detachment Of Device Component 984 984
Break 753 753
Adverse Event Without Identified Device or Use Problem 751 751
Display or Visual Feedback Problem 723 723
Overheating of Device 409 409
Application Program Freezes, Becomes Nonfunctional 173 173
Low Audible Alarm 160 160
Alarm Not Visible 120 120
Output Problem 101 101
Operating System Version or Upgrade Problem 55 55
Communication or Transmission Problem 43 43
Insufficient Information 33 33
Environmental Particulates 30 30
Retraction Problem 27 27
Failure to Calibrate 19 19
Failure to Power Up 18 18
Gel Leak 17 17
Battery Problem 17 17
Calibration Error 15 15
Unintended Electrical Shock 15 15
Disconnection 13 13
Device Issue 13 13
Failure to Sense 11 11
Incomplete or Inadequate Connection 11 11
Unintended Ejection 6 6
Arcing at Paddles 5 5
Date/Time-Related Software Problem 5 5
Calibration Problem 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Calcified 3 3
False Alarm 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Decrease in Pressure 2 2
Fire 2 2
Failure to Charge 2 2
Delayed Alarm 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Component 2 2
Improper Alarm 2 2
Activation, Positioning or SeparationProblem 2 2
Device Markings/Labelling Problem 1 1
Impedance Problem 1 1
Application Program Problem 1 1
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Vibration 1 1
Loss of Threshold 1 1
Obstruction of Flow 1 1
Incorrect Or Inadequate Test Results 1 1
Radiofrequency Interference (RFI) 1 1
Failure to Deliver 1 1
Device Alarm System 1 1
Premature Discharge of Battery 1 1
Computer Software Problem 1 1
Failure to Conduct 1 1
Insufficient Cooling 1 1
Fluid Leak 1 1
Image Orientation Incorrect 1 1
Electrical /Electronic Property Problem 1 1
Off-Label Use 1 1
Looping 1 1
Unintended System Motion 1 1
Issue With Displayed Error Message 1 1
Mechanical Jam 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Data Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 232659 232659
No Clinical Signs, Symptoms or Conditions 6349 6349
No Known Impact Or Consequence To Patient 1684 1684
Hypoglycemia 913 913
Loss of consciousness 423 423
Reaction 357 357
Erythema 217 217
Hyperglycemia 156 156
Itching Sensation 149 149
Foreign Body In Patient 115 115
Pain 107 107
Seizures 106 106
Scarring 99 99
Blood Loss 92 92
Diabetic Ketoacidosis 90 90
Malaise 89 89
Skin Irritation 89 89
Confusion/ Disorientation 88 88
Vomiting 72 72
Rash 65 65
Sweating 60 60
Dizziness 57 57
Shaking/Tremors 52 52
Swelling 50 50
Purulent Discharge 50 50
Fall 44 44
Injury 41 41
Unspecified Infection 39 39
Discomfort 36 36
Skin Discoloration 31 31
Skin Inflammation 28 28
Nausea 25 25
Burning Sensation 20 20
Weakness 19 19
Lethargy 17 17
Collapse 15 15
Fatigue 15 15
Fainting 15 15
Bruise/Contusion 14 14
Coma 14 14
Urticaria 14 14
Dehydration 12 12
Headache 11 11
Inflammation 11 11
Fluid Discharge 11 11
Death 8 8
Abscess 7 7
Fever 7 7
Irritation 7 7
Blurred Vision 7 7
Cognitive Changes 7 7
No Information 6 6
Convulsion, Tonic 6 6
Diaphoresis 6 6
Head Injury 6 6
Cellulitis 6 6
Chest Pain 6 6
Contusion 6 6
Memory Loss/Impairment 5 5
Staphylococcus Aureus 5 5
Insufficient Information 5 5
Pregnancy 4 4
Skin Tears 4 4
Concussion 4 4
Increased Sensitivity 4 4
Burn(s) 4 4
Bacterial Infection 3 3
Syncope 3 3
Abdominal Pain 3 3
Hemorrhage/Bleeding 3 3
Visual Impairment 3 3
Wheal(s) 3 3
Convulsion, Clonic 3 3
Patient Problem/Medical Problem 3 3
Convulsion/Seizure 3 3
Pallor 3 3
Chills 2 2
Abdominal Cramps 2 2
Palpitations 2 2
Vertigo 2 2
Shock 2 2
Renal Failure 2 2
Muscle Weakness 2 2
Myocardial Infarction 2 2
Bone Fracture(s) 2 2
Hematoma 2 2
Abrasion 2 2
Cardiac Arrest 2 2
Dyspnea 1 1
Edema 1 1
Macular Edema 1 1
Arrhythmia 1 1
Cyst(s) 1 1
Hemorrhage, Cerebral 1 1
Hypothermia 1 1
Incontinence 1 1
Foreign Body Reaction 1 1
Foreign Body Sensation in Eye 1 1
Diarrhea 1 1
Muscle Spasm(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dexcom Inc II Mar-25-2020
2 Tandem Diabetes Care Inc II Jun-10-2022
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