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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
Definition The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
Product CodeMDS
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
40 79 47 14 13 7

MDR Year MDR Reports MDR Events
2017 48852 48852
2018 9085 9085
2019 2124 2124
2020 913 913
2021 529 529
2022 7236 7236

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 20386 20386
Invalid Sensing 12129 12129
Device Displays Incorrect Message 11304 11304
Use of Device Problem 6676 6676
Imprecision 5629 5629
Communication or Transmission Problem 4550 4550
Defective Alarm 2129 2129
Inappropriate or Unexpected Reset 1973 1973
No Audible Alarm 1848 1848
Device Inoperable 1508 1508
Device Operates Differently Than Expected 1024 1024
Unable to Obtain Readings 929 929
Battery Problem 897 897
Adverse Event Without Identified Device or Use Problem 712 712
Component Missing 468 468
Display or Visual Feedback Problem 466 466
Unexpected Shutdown 455 455
Detachment Of Device Component 405 405
No Device Output 296 296
Break 261 261
Structural Problem 255 255
Patient-Device Incompatibility 254 254
Detachment of Device or Device Component 215 215
Appropriate Term/Code Not Available 213 213
Physical Resistance/Sticking 205 205
Incorrect, Inadequate or Imprecise Result or Readings 185 185
Low Battery 170 170
Overheating of Device 126 126
Unexpected Therapeutic Results 118 118
Calibration Problem 96 96
Premature End-of-Life Indicator 87 87
Image Display Error/Artifact 78 78
Product Quality Problem 68 68
Fail-Safe Problem 60 60
Therapeutic or Diagnostic Output Failure 50 50
Retraction Problem 47 47
No Apparent Adverse Event 44 44
Failure of Device to Self-Test 42 42
Failure to Power Up 40 40
Unintended Application Program Shut Down 37 37
Connection Problem 33 33
No Display/Image 31 31
Insufficient Information 30 30
Failure to Read Input Signal 27 27
Low Audible Alarm 25 25
Moisture Damage 25 25
Incorrect Measurement 24 24
Fracture 24 24
Electrical /Electronic Property Problem 23 23
Defective Device 23 23
Defective Component 22 22
Difficult to Remove 21 21
Patient Device Interaction Problem 21 21
Loss of or Failure to Bond 20 20
Output Problem 19 19
Device Alarm System 18 18
Premature Discharge of Battery 16 16
Computer Software Problem 16 16
Moisture or Humidity Problem 16 16
Device Issue 15 15
Low Test Results 13 13
Device Sensing Problem 13 13
Material Twisted/Bent 11 11
Low Readings 11 11
Failure to Prime 11 11
Air Leak 10 10
Material Integrity Problem 10 10
Device Ingredient or Reagent Problem 9 9
Device Markings/Labelling Problem 9 9
Failure to Deliver 9 9
Device Fell 9 9
Failure to Sense 8 8
High Test Results 8 8
Activation, Positioning or Separation Problem 8 8
Failure to Charge 8 8
Bent 7 7
False Reading From Device Non-Compliance 7 7
Manufacturing, Packaging or Shipping Problem 7 7
High Readings 6 6
Incorrect Or Inadequate Test Results 6 6
Device Slipped 6 6
Failure To Adhere Or Bond 6 6
Alarm Not Visible 5 5
Crack 5 5
Difficult to Insert 5 5
Separation Failure 5 5
Incomplete or Inadequate Connection 5 5
Temperature Problem 5 5
Packaging Problem 4 4
Device Handling Problem 4 4
Failure to Calibrate 4 4
Sticking 4 4
Improper or Incorrect Procedure or Method 4 4
Kinked 4 4
Fluid/Blood Leak 4 4
Entrapment of Device 3 3
Disconnection 3 3
Loose or Intermittent Connection 3 3
Inaccurate Delivery 3 3
Material Separation 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 58839 58839
No Clinical Signs, Symptoms or Conditions 6571 6571
Insufficient Information 825 825
No Known Impact Or Consequence To Patient 640 640
Hypoglycemia 469 469
Itching Sensation 319 319
Reaction 290 290
Rash 285 285
Hyperglycemia 284 284
Erythema 258 258
Loss of consciousness 144 144
Skin Irritation 143 143
Pain 104 104
Scarring 81 81
Caustic/Chemical Burns 63 63
Swelling 62 62
Unspecified Infection 60 60
Foreign Body In Patient 57 57
Purulent Discharge 50 50
Seizures 48 48
Bruise/Contusion 45 45
Hypersensitivity/Allergic reaction 44 44
Fluid Discharge 43 43
Diabetic Ketoacidosis 37 37
Discomfort 37 37
Burning Sensation 30 30
Death 28 28
Skin Inflammation 28 28
Blood Loss 27 27
Hematoma 27 27
Burn(s) 26 26
Skin Inflammation/ Irritation 26 26
Inflammation 25 25
Hemorrhage/Bleeding 23 23
Confusion/ Disorientation 23 23
Blister 22 22
Irritation 21 21
Cognitive Changes 20 20
Skin Discoloration 19 19
No Information 18 18
Vomiting 17 17
Fainting 15 15
Fall 15 15
No Code Available 14 14
Coma 13 13
Dizziness 12 12
Discharge 12 12
Scar Tissue 12 12
Malaise 11 11
Impaired Healing 11 11
Skin Burning Sensation 11 11
Superficial (First Degree) Burn 11 11
Sweating 10 10
Local Reaction 10 10
Peeling 9 9
Injury 9 9
Urticaria 9 9
Myocardial Infarction 8 8
Nausea 8 8
Shock 7 7
Tissue Damage 7 7
Fatigue 7 7
Shaking/Tremors 7 7
Contact Dermatitis 7 7
Skin Disorders 6 6
Patient Problem/Medical Problem 6 6
Burn, Thermal 6 6
Weakness 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Abscess 5 5
Partial thickness (Second Degree) Burn 5 5
Pregnancy 5 5
Skin Tears 5 5
Convulsion, Clonic 4 4
Device Embedded In Tissue or Plaque 4 4
Tissue Breakdown 4 4
Lethargy 4 4
Bone Fracture(s) 4 4
Headache 3 3
Abrasion 3 3
Cellulitis 3 3
Dehydration 3 3
Skin Erosion 3 3
Overdose 3 3
Reaction to Medicinal Component of Device 3 3
Swelling/ Edema 3 3
Cancer 3 3
Anxiety 3 3
Complaint, Ill-Defined 3 3
Sleep Dysfunction 3 3
Sudden Cardiac Death 3 3
Needle Stick/Puncture 2 2
Reaction, Injection Site 2 2
Collapse 2 2
Wheal(s) 2 2
Heart Failure 2 2
Concussion 2 2
Pneumonia 2 2
Renal Disease, End Stage 2 2
Renal Failure 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Dexcom Inc II Mar-25-2020
2 Dexcom Inc II Jan-31-2020
3 Medtronic Inc. II May-17-2021
4 Medtronic Inc. II Jan-11-2021
5 Medtronic Inc. II Sep-17-2020
6 Medtronic Inc. II May-22-2020
7 Medtronic Inc. II May-03-2019
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