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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)
2019 2020 2021 2022 2023 2024
1 0 0 0 0 0

MDR Year MDR Reports MDR Events
2019 44509 44509
2020 10579 10579
2021 4943 4943
2022 1378 1378
2023 6374 6374
2024 4972 4972

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 27745 27745
No Device Output 24054 24054
Communication or Transmission Problem 3919 3919
Imprecision 3905 3905
Premature End-of-Life Indicator 3516 3516
Detachment of Device or Device Component 2145 2145
Unable to Obtain Readings 2115 2115
Unexpected Shutdown 1847 1847
Display or Visual Feedback Problem 1253 1253
Connection Problem 1163 1163
Unintended Application Program Shut Down 1092 1092
Appropriate Term/Code Not Available 993 993
Defective Alarm 968 968
Inappropriate or Unexpected Reset 645 645
Device Displays Incorrect Message 611 611
Calibration Problem 519 519
Break 494 494
Incorrect, Inadequate or Imprecise Result or Readings 417 417
No Audible Alarm 378 378
Battery Problem 344 344
Adverse Event Without Identified Device or Use Problem 137 137
Overheating of Device 106 106
Low Audible Alarm 86 86
Application Program Freezes, Becomes Nonfunctional 84 84
Alarm Not Visible 80 80
Failure of Device to Self-Test 59 59
Computer Software Problem 43 43
Operating System Version or Upgrade Problem 40 40
Moisture or Humidity Problem 28 28
Use of Device Problem 28 28
Insufficient Information 14 14
Output Problem 11 11
Failure to Calibrate 7 7
Unintended Electrical Shock 6 6
Unintended Ejection 5 5
Arcing at Paddles 4 4
Unexpected Therapeutic Results 4 4
Obstruction of Flow 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Packaging Problem 3 3
Device Alarm System 3 3
Retraction Problem 3 3
Failure to Sense 3 3
Failure to Power Up 2 2
Application Network Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unauthorized Access to Computer System 1 1
Mechanical Jam 1 1
Device Handling Problem 1 1
Environmental Compatibility Problem 1 1
Defective Component 1 1
Failure to Deliver 1 1
High Readings 1 1
Defective Device 1 1
Delivered as Unsterile Product 1 1
Unintended System Motion 1 1
Failure to Conduct 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 54309 54309
No Clinical Signs, Symptoms or Conditions 17628 17628
Hypoglycemia 338 338
Hyperglycemia 221 221
Loss of consciousness 166 166
Hemorrhage/Bleeding 96 96
Reaction 63 63
Diabetic Ketoacidosis 51 51
Erythema 39 39
Vomiting 37 37
Foreign Body In Patient 36 36
No Known Impact Or Consequence To Patient 35 35
Pain 35 35
Confusion/ Disorientation 29 29
Malaise 20 20
Sweating 19 19
Fall 19 19
Seizures 18 18
Dizziness 17 17
Discomfort 16 16
Skin Irritation 16 16
Itching Sensation 15 15
Blood Loss 15 15
Fatigue 13 13
Purulent Discharge 12 12
Nausea 11 11
Injury 10 10
Insufficient Information 10 10
Shaking/Tremors 9 9
Scarring 9 9
Swelling 9 9
Weakness 9 9
Rash 9 9
Unspecified Infection 8 8
Collapse 7 7
Headache 7 7
Head Injury 5 5
Bruise/Contusion 5 5
Diaphoresis 5 5
Burning Sensation 5 5
Skin Inflammation 5 5
Lethargy 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Blurred Vision 4 4
Cardiac Arrest 4 4
Contusion 4 4
Hematoma 4 4
Memory Loss/Impairment 3 3
Chest Pain 3 3
Coma 3 3
Electrolyte Imbalance 3 3
Polydipsia 3 3
Skin Inflammation/ Irritation 3 3
Convulsion/Seizure 3 3
Cognitive Changes 2 2
Wheal(s) 2 2
Concussion 2 2
Inflammation 2 2
Increased Sensitivity 2 2
Bacterial Infection 2 2
Death 2 2
Dehydration 2 2
Fainting 2 2
Muscle Weakness 2 2
Myocardial Infarction 2 2
Fever 2 2
Bone Fracture(s) 1 1
Hemorrhage, Cerebral 1 1
Hypothermia 1 1
Incontinence 1 1
Dyspnea 1 1
Cellulitis 1 1
Burn(s) 1 1
Abdominal Pain 1 1
Abrasion 1 1
Abscess 1 1
Arrhythmia 1 1
Shock 1 1
Skin Discoloration 1 1
Renal Failure 1 1
Urinary Tract Infection 1 1
Urticaria 1 1
Anxiety 1 1
Brain Injury 1 1
Palpitations 1 1
Pallor 1 1
Skin Tears 1 1
Caustic/Chemical Burns 1 1
Speech Disorder 1 1
Respiratory Arrest 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Skin Infection 1 1
No Information 1 1
No Code Available 1 1
Balance Problems 1 1
Urinary Incontinence 1 1
Hypoglycemic Shock 1 1
Fluid Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dexcom Inc II Mar-25-2020
2 Tandem Diabetes Care Inc II Sep-26-2022
3 Tandem Diabetes Care Inc II Jun-10-2022
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