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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)
2019 2020 2021 2022 2023 2024
47 14 13 8 3 3

MDR Year MDR Reports MDR Events
2019 2124 2124
2020 912 912
2021 531 531
2022 10571 10571
2023 13869 13869
2024 1971 1971

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 14646 14646
Communication or Transmission Problem 7183 7183
Battery Problem 3642 3642
Computer Software Problem 3090 3090
Display or Visual Feedback Problem 1019 1019
Physical Resistance/Sticking 942 942
Appropriate Term/Code Not Available 810 810
Calibration Problem 543 543
Unable to Obtain Readings 497 497
Incorrect, Inadequate or Imprecise Result or Readings 427 427
Break 373 373
Imprecision 344 344
Failure of Device to Self-Test 294 294
No Device Output 275 275
Patient-Device Incompatibility 247 247
Unexpected Therapeutic Results 245 245
Unexpected Shutdown 231 231
Use of Device Problem 188 188
Adverse Event Without Identified Device or Use Problem 147 147
Detachment of Device or Device Component 130 130
No Apparent Adverse Event 111 111
Product Quality Problem 97 97
Defective Alarm 89 89
Therapeutic or Diagnostic Output Failure 65 65
No Audible Alarm 63 63
Inappropriate or Unexpected Reset 63 63
Device Displays Incorrect Message 60 60
Application Network Problem 57 57
Defective Device 51 51
Fracture 51 51
Premature End-of-Life Indicator 41 41
Patient Device Interaction Problem 37 37
Moisture or Humidity Problem 34 34
Unintended Application Program Shut Down 34 34
Difficult to Remove 34 34
Device Sensing Problem 34 34
Loss of or Failure to Bond 27 27
Material Integrity Problem 24 24
Low Readings 24 24
Defective Component 23 23
Activation Failure 23 23
Device Alarm System 22 22
Overheating of Device 21 21
Output Problem 20 20
Problem with Software Installation 20 20
Packaging Problem 19 19
Connection Problem 18 18
Material Twisted/Bent 16 16
Manufacturing, Packaging or Shipping Problem 14 14
Device Markings/Labelling Problem 13 13
Low Test Results 11 11
High Readings 10 10
Activation Problem 9 9
Activation, Positioning or Separation Problem 9 9
Device Ingredient or Reagent Problem 9 9
Failure to Sense 8 8
Device Slipped 8 8
Difficult to Insert 7 7
Device Fell 7 7
Retraction Problem 7 7
Unauthorized Access to Computer System 7 7
Obstruction of Flow 6 6
Insufficient Information 6 6
Low Audible Alarm 5 5
Separation Failure 5 5
Entrapment of Device 4 4
Failure to Calibrate 4 4
Device Dislodged or Dislocated 3 3
Failure to Transmit Record 3 3
Data Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Intermittent Infusion 3 3
Material Separation 3 3
Material Protrusion/Extrusion 3 3
Mechanical Jam 3 3
Operating System Version or Upgrade Problem 3 3
Protective Measures Problem 2 2
Application Program Problem 2 2
Component or Accessory Incompatibility 2 2
Application Program Problem: Medication Error 2 2
Off-Label Use 2 2
Device Emits Odor 2 2
Device-Device Incompatibility 2 2
Disconnection 2 2
Loose or Intermittent Connection 2 2
Noise, Audible 2 2
Power Problem 2 2
Application Program Version or Upgrade Problem 2 2
Decreased Sensitivity 2 2
High Test Results 2 2
Delivered as Unsterile Product 2 2
Incorrect Measurement 2 2
No Display/Image 2 2
Component Missing 2 2
Difficult or Delayed Separation 1 1
Inadequate Instructions for Healthcare Professional 1 1
Unintended Ejection 1 1
Erratic Results 1 1
Circuit Failure 1 1
Application Program Freezes, Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25030 25030
No Consequences Or Impact To Patient 2251 2251
Insufficient Information 1080 1080
Hyperglycemia 387 387
No Known Impact Or Consequence To Patient 357 357
Hypoglycemia 263 263
Rash 208 208
Itching Sensation 192 192
Erythema 97 97
Skin Irritation 83 83
Pain 71 71
Reaction 68 68
Caustic/Chemical Burns 65 65
Swelling 47 47
Hypersensitivity/Allergic reaction 47 47
Bruise/Contusion 43 43
Hemorrhage/Bleeding 39 39
Discomfort 39 39
Scarring 38 38
Skin Inflammation/ Irritation 32 32
Burning Sensation 31 31
Hematoma 31 31
Blister 30 30
Loss of consciousness 24 24
Fluid Discharge 23 23
Inflammation 22 22
Unspecified Infection 20 20
Irritation 16 16
Purulent Discharge 16 16
Skin Inflammation 15 15
Foreign Body In Patient 14 14
Skin Burning Sensation 14 14
Discharge 12 12
Scar Tissue 12 12
Skin Discoloration 11 11
Diabetic Ketoacidosis 11 11
Impaired Healing 11 11
Burn(s) 11 11
Superficial (First Degree) Burn 11 11
No Code Available 9 9
Local Reaction 9 9
Anxiety 8 8
Contact Dermatitis 8 8
Blood Loss 8 8
Confusion/ Disorientation 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Urticaria 7 7
Vomiting 6 6
Dizziness 6 6
Peeling 6 6
Nausea 6 6
Swelling/ Edema 6 6
Burn, Thermal 6 6
Skin Disorders 6 6
Skin Infection 6 6
No Information 6 6
Fatigue 5 5
Tissue Damage 5 5
Dyspnea 4 4
Device Embedded In Tissue or Plaque 4 4
Shaking/Tremors 4 4
Skin Tears 4 4
Partial thickness (Second Degree) Burn 4 4
Tissue Breakdown 3 3
Sleep Dysfunction 3 3
Reaction to Medicinal Component of Device 3 3
Emotional Changes 3 3
Cellulitis 3 3
Overdose 3 3
Muscle Weakness 3 3
Seizures 3 3
Convulsion, Clonic 3 3
Urinary Tract Infection 3 3
Malaise 3 3
Needle Stick/Puncture 3 3
Sweating 2 2
Weakness 2 2
Death 2 2
Abrasion 2 2
Lethargy 2 2
Syncope/Fainting 2 2
Unspecified Mental, Emotional or Behavioural Problem 1 1
Dry Mouth 1 1
Kidney Infection 1 1
Cancer 1 1
Localized Skin Lesion 1 1
Unspecified Tissue Injury 1 1
Implant Pain 1 1
Increased Appetite 1 1
Electric Shock 1 1
Cognitive Changes 1 1
No Patient Involvement 1 1
Test Result 1 1
Double Capsule 1 1
Bacterial Infection 1 1
Cardiomyopathy 1 1
Abdominal Pain 1 1
Stroke/CVA 1 1
Foreign Body Reaction 1 1
Headache 1 1

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
8 Medtronic MiniMed II Jan-01-2023
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