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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

MDR Year MDR Reports MDR Events
2021 590 849
2022 10571 12138
2023 13882 13927
2024 4137 4138
2025 2835 2835
2026 732 732

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 18061 18184
Communication or Transmission Problem 7194 7400
Battery Problem 3911 3930
Computer Software Problem 3472 4633
Display or Visual Feedback Problem 1085 1089
Incorrect, Inadequate or Imprecise Result or Readings 1061 1175
Physical Resistance/Sticking 940 946
Appropriate Term/Code Not Available 904 945
Calibration Problem 810 813
Break 371 377
Unexpected Therapeutic Results 300 300
Failure of Device to Self-Test 292 292
Use of Device Problem 196 196
Data Problem 192 195
No Apparent Adverse Event 110 128
Patient-Device Incompatibility 102 148
Application Network Problem 81 81
Adverse Event Without Identified Device or Use Problem 70 95
Product Quality Problem 58 101
Therapeutic or Diagnostic Output Failure 58 147
Fracture 55 55
Unable to Obtain Readings 50 75
Device Alarm System 49 53
Defective Device 45 110
Patient Device Interaction Problem 41 46
No Device Output 39 39
Inappropriate or Unexpected Reset 37 37
Difficult to Remove 35 47
Moisture or Humidity Problem 34 34
Device Sensing Problem 30 48
Detachment of Device or Device Component 27 45
Low Readings 25 32
Material Integrity Problem 25 25
Activation Failure 24 25
Problem with Software Installation 23 28
Packaging Problem 21 22
Output Problem 19 29
Loss of or Failure to Bond 19 22
Imprecision 18 18
Unexpected Shutdown 18 18
Unauthorized Access to Computer System 18 18
Manufacturing, Packaging or Shipping Problem 17 17
Unintended Application Program Shut Down 17 17
Material Twisted/Bent 16 22
Defective Alarm 14 14
Defective Component 13 23
Device Markings/Labelling Problem 12 15
Device Ingredient or Reagent Problem 11 15
High Readings 9 14
Connection Problem 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30215 31569
Insufficient Information 1088 1387
Hyperglycemia 654 694
Hypoglycemia 405 448
Hemorrhage/Bleeding 147 176
Rash 89 128
Itching Sensation 75 106
Erythema 54 70
Bruise/Contusion 40 46
Skin Inflammation/ Irritation 36 51
Pain 35 57
Diabetic Ketoacidosis 35 44
Discomfort 33 42
Blister 31 41
Hematoma 31 31
Caustic/Chemical Burns 23 25
Hypersensitivity/Allergic reaction 23 36
Reaction 18 25
Loss of consciousness 18 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 35
Skin Burning Sensation 13 15
Malaise 13 13
Skin Irritation 12 22
Fatigue 12 12
Superficial (First Degree) Burn 11 17
Scar Tissue 11 20
Burning Sensation 11 15
Swelling/ Edema 10 10
Vomiting 10 10
Unspecified Infection 10 11
Nausea 9 9
Purulent Discharge 8 10
Confusion/ Disorientation 8 8
Fluid Discharge 8 9
Hypoxia 8 8
Anxiety 7 11
Scarring 7 10
Inflammation 7 10
Contact Dermatitis 7 9
Shaking/Tremors 6 9
Urticaria 6 6
Skin Infection 6 6
Foreign Body In Patient 6 7
Skin Disorders 5 10
Polydipsia 5 5
Skin Discoloration 5 5
Dizziness 4 4
Diaphoresis 4 4
Skin Tears 4 7
Headache 4 4

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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