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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)
2016 2017 2018 2019 2020 2021
52 40 79 47 14 8

MDR Year MDR Reports MDR Events
2016 97189 97189
2017 48854 48854
2018 9085 9085
2019 2153 2153
2020 915 915
2021 369 369

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 42832 42832
Wireless Communication Problem 39227 39227
Invalid Sensing 25579 25579
Device Operates Differently Than Expected 20823 20823
Use of Device Problem 14896 14896
No Audible Alarm 9409 9409
Imprecision 5622 5622
Defective Alarm 5347 5347
Inappropriate or Unexpected Reset 3119 3119
Device Inoperable 2410 2410
Adverse Event Without Identified Device or Use Problem 1937 1937
Component Missing 1219 1219
Detachment Of Device Component 1153 1153
Break 1139 1139
Unable to Obtain Readings 917 917
Crack 818 818
Structural Problem 786 786
Display or Visual Feedback Problem 595 595
Poor Quality Image 578 578
Unexpected Shutdown 450 450
Image Display Error/Artifact 320 320
No Device Output 294 294
Low Battery 264 264
Moisture Damage 239 239
Overheating of Device 234 234
Patient-Device Incompatibility 233 233
Incorrect, Inadequate or Imprecise Resultor Readings 226 226
Detachment of Device or Device Component 216 216
Failure to Power Up 183 183
Fail-Safe Problem 173 173
No Display/Image 152 152
Incorrect Or Inadequate Test Results 144 144
Failure to Prime 135 135
Appropriate Term/Code Not Available 135 135
Connection Problem 119 119
Battery Problem 105 105
Difficult or Delayed Activation 88 88
Electrical /Electronic Property Problem 88 88
Incorrect Measurement 85 85
Premature End-of-Life Indicator 82 82
Communication or Transmission Problem 81 81
Failure to Read Input Signal 69 69
Device Stops Intermittently 66 66
Premature Discharge of Battery 64 64
Retraction Problem 54 54
Operating System Version or Upgrade Problem 54 54
Improper or Incorrect Procedure or Method 52 52
Product Quality Problem 49 49
Insufficient Information 47 47
Device Alarm System 43 43
Data Problem 40 40
Inaccurate Delivery 40 40
Device Issue 40 40
Fracture 35 35
Low Audible Alarm 30 30
Therapeutic or Diagnostic Output Failure 29 29
Output Problem 27 27
Temperature Problem 24 24
Failure to Sense 24 24
False Reading From Device Non-Compliance 23 23
Failure to Charge 22 22
Unintended Application Program Shut Down 22 22
Material Discolored 22 22
Defective Device 21 21
Loss of or Failure to Bond 20 20
Occlusion Within Device 20 20
Vibration 20 20
Calibration Problem 19 19
Defective Component 18 18
Difficult to Remove 16 16
Loss of Power 16 16
Device Sensing Problem 14 14
High Test Results 14 14
Failure to Deliver 12 12
Air Leak 11 11
Application Interface Becomes Non-Functional Or Program Exits Abnormally 11 11
Low Test Results 10 10
Sticking 10 10
Self-Activation or Keying 10 10
Patient Device Interaction Problem 10 10
Device Ingredient or Reagent Problem 9 9
Scratched Material 9 9
Physical Resistance/Sticking 8 8
Device Fell 8 8
Low Readings 8 8
Failure To Adhere Or Bond 8 8
Bent 8 8
Device Slipped 8 8
Date/Time-Related Software Problem 7 7
Activation, Positioning or SeparationProblem 7 7
Unexpected Therapeutic Results 7 7
Moisture or Humidity Problem 7 7
Material Integrity Problem 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Partial Blockage 6 6
Loose or Intermittent Connection 6 6
Device Operational Issue 6 6
Device Handling Problem 6 6
Noise, Audible 5 5
Material Twisted/Bent 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 148425 148425
No Known Impact Or Consequence To Patient 6244 6244
Hypoglycemia 975 975
Reaction 780 780
Erythema 763 763
Itching Sensation 647 647
Rash 555 555
Hyperglycemia 349 349
Loss of consciousness 331 331
Skin Irritation 263 263
No Clinical Signs, Symptoms or Conditions 240 240
Pain 159 159
Purulent Discharge 154 154
Injury 153 153
Scarring 139 139
Foreign Body In Patient 135 135
Seizures 131 131
Death 128 128
Skin Inflammation 110 110
Diabetic Ketoacidosis 105 105
Unspecified Infection 97 97
Swelling 87 87
Fluid Discharge 69 69
Confusion/ Disorientation 64 64
Urticaria 63 63
Caustic/Chemical Burns 62 62
Burning Sensation 54 54
Burn(s) 48 48
Hypersensitivity/Allergic reaction 42 42
Inflammation 39 39
Vomiting 39 39
Blood Loss 39 39
Discomfort 38 38
Dizziness 36 36
Irritation 33 33
Skin Discoloration 32 32
Cognitive Changes 32 32
Sweating 31 31
Insufficient Information 31 31
Malaise 30 30
Nausea 30 30
Bruise/Contusion 29 29
No Information 29 29
Fainting 27 27
Fall 27 27
Coma 25 25
Fatigue 21 21
Skin Inflammation/ Irritation 20 20
Myocardial Infarction 20 20
Hemorrhage/Bleeding 19 19
Abscess 19 19
Discharge 17 17
Bone Fracture(s) 17 17
Scar Tissue 17 17
Patient Problem/Medical Problem 16 16
No Code Available 15 15
Blister 15 15
Lethargy 14 14
Cancer 13 13
Dehydration 13 13
Polydipsia 13 13
Impaired Healing 12 12
Pneumonia 11 11
Shock 11 11
Blurred Vision 11 11
Headache 11 11
Renal Failure 11 11
Wheal(s) 11 11
Skin Burning Sensation 11 11
Superficial (First Degree) Burn 11 11
Local Reaction 10 10
Shaking/Tremors 10 10
Weakness 9 9
Abdominal Pain 9 9
Cellulitis 9 9
Urinary Frequency 9 9
Peeling 9 9
Congestive Heart Failure 8 8
Sudden Cardiac Death 8 8
Fever 7 7
Staphylococcus Aureus 7 7
High Blood Pressure/ Hypertension 7 7
Concussion 7 7
Cardiac Arrest 7 7
Tissue Damage 7 7
Heart Failure 6 6
Stroke/CVA 6 6
Burn, Thermal 6 6
Complaint, Ill-Defined 6 6
Device Embedded In Tissue or Plaque 6 6
Dyspnea 6 6
Pregnancy 6 6
Skin Tears 5 5
Contact Dermatitis 5 5
Bacterial Infection 5 5
Laceration(s) 5 5
Virus 5 5
Urinary Tract Infection 5 5
Tachycardia 4 4
Overdose 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Dexcom Inc II Mar-25-2020
2 Dexcom Inc II Jan-31-2020
3 Dexcom Inc I Apr-11-2016
4 Medtronic Inc. II May-17-2021
5 Medtronic Inc. II Jan-11-2021
6 Medtronic Inc. II Sep-17-2020
7 Medtronic Inc. II May-22-2020
8 Medtronic Inc. II May-03-2019
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