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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)
2021 2022 2023 2024 2025 2026
13 8 3 4 7 4

MDR Year MDR Reports MDR Events
2021 590 849
2022 10571 12138
2023 13881 13926
2024 4137 4138
2025 2835 2835
2026 1487 1487

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 18604 18725
Communication or Transmission Problem 7156 7317
Battery Problem 3578 3585
Computer Software Problem 3396 4466
Display or Visual Feedback Problem 1073 1073
Incorrect, Inadequate or Imprecise Result or Readings 1035 1039
Physical Resistance/Sticking 933 936
Appropriate Device Problem Term/Code Not Available 905 944
Calibration Problem 822 824
Break 362 364
Unexpected Therapeutic Results 300 300
Failure of Device to Self-Test 292 292
Data Problem 280 280
Use of Device Problem 185 185
No Apparent Adverse Event 110 128
Application Network Problem 83 83
Fracture 55 55
Device Alarm System 54 55
Inappropriate or Unexpected Reset 38 38
No Device Output 36 36
Moisture or Humidity Problem 35 35
Adverse Event Without Identified Device or Use Problem 34 35
Unable to Obtain Readings 31 33
Difficult to Remove 29 30
Material Integrity Problem 24 24
Problem with Software Installation 23 28
Patient Device Interaction Problem 21 22
Packaging Problem 20 20
Unauthorized Access to Computer System 20 20
Imprecision 18 18
Unintended Application Program Shut Down 17 17
Material Twisted/Bent 13 13
Unexpected Shutdown 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Detachment of Device or Device Component 12 12
Loss of or Failure to Bond 11 11
Defective Alarm 8 8
Delivered as Unsterile Product 7 7
Premature End-of-Life Indicator 7 7
Obstruction of Flow 6 7
No Audible Alarm 6 6
Activation Problem 6 6
Product Quality Problem 5 5
Connection Problem 4 4
Low Readings 3 3
Device Markings/Labelling Problem 3 3
Power Problem 2 2
Overheating of Device 2 2
Insufficient Device Problem Information 2 2
Operating System Version or Upgrade Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30868 32222
Insufficient Information 1091 1390
Hyperglycemia 704 744
Hypoglycemia 436 479
Hemorrhage/Blood Loss/Bleeding 162 191
Rash 89 128
Itching Sensation 76 107
Erythema 54 70
Bruise/Contusion 48 54
Elevated ketones/Diabetic Ketoacidosis 38 47
Skin Inflammation/ Irritation 37 52
Pain 35 57
Discomfort 33 42
Hematoma 31 31
Blister 31 41
Hypersensitivity/Allergic reaction 24 37
Caustic/Chemical Burns 23 25
Loss of consciousness 20 21
Reaction 18 25
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 16 38
Fatigue 15 15
Malaise 14 14
Skin Burning Sensation 13 15
Skin Irritation 12 22
Vomiting 12 12
Superficial (First Degree) Burn 11 17
Scar Tissue 11 20
Burning Sensation 11 15
Swelling/ Edema 10 10
Unspecified Infection 10 11
Nausea 9 9
Purulent Discharge 8 10
Confusion/ Disorientation 8 8
Fluid Discharge 8 9
Hypoxia 8 8
Contact Dermatitis 7 9
Scarring 7 10
Anxiety 7 11
Inflammation 7 10
Shaking/Tremors 6 9
Skin Infection 6 6
Foreign Body In Patient 6 7
Urticaria 6 6
Polydipsia 5 5
Skin Disorders 5 10
Skin Discoloration 5 5
Dizziness 5 5
Convulsion, Clonic 4 4
Bone Cement Implantation Syndrome 4 4
Skin Tears 4 7

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. II May-17-2021
2 Medtronic Inc. II Jan-11-2021
3 Medtronic MiniMed II Jan-01-2023
4 Medtronic MiniMed, Inc. II Oct-02-2025
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