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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)
2020 2021 2022 2023 2024 2025
14 13 8 3 4 5

MDR Year MDR Reports MDR Events
2020 935 1216
2021 590 847
2022 10571 10698
2023 13882 13887
2024 4139 4139
2025 1965 1965

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 17035 17037
Communication or Transmission Problem 7201 7219
Battery Problem 3854 3862
Computer Software Problem 3427 3427
Display or Visual Feedback Problem 1074 1081
Incorrect, Inadequate or Imprecise Result or Readings 957 1103
Physical Resistance/Sticking 946 954
Appropriate Term/Code Not Available 917 918
Calibration Problem 769 775
Break 381 411
Unexpected Therapeutic Results 298 298
Failure of Device to Self-Test 292 292
Patient-Device Incompatibility 227 376
Use of Device Problem 196 196
Adverse Event Without Identified Device or Use Problem 137 187
Unable to Obtain Readings 133 161
No Apparent Adverse Event 110 110
No Device Output 110 110
Product Quality Problem 94 169
Data Problem 90 93
Application Network Problem 80 80
Imprecision 72 72
Therapeutic or Diagnostic Output Failure 71 171
Detachment of Device or Device Component 55 83
Fracture 54 54
Defective Device 53 125
Unexpected Shutdown 51 51
Patient Device Interaction Problem 43 48
Inappropriate or Unexpected Reset 41 41
Difficult to Remove 38 54
Device Alarm System 35 38
Moisture or Humidity Problem 34 34
Device Sensing Problem 31 49
Material Integrity Problem 26 26
Low Readings 25 37
Activation Failure 24 25
Loss of or Failure to Bond 23 33
Problem with Software Installation 23 23
Device Displays Incorrect Message 22 65
Defective Alarm 21 21
Unintended Application Program Shut Down 21 21
Packaging Problem 21 22
Output Problem 19 29
Material Twisted/Bent 19 29
Premature End-of-Life Indicator 18 18
Manufacturing, Packaging or Shipping Problem 17 17
No Audible Alarm 17 17
Defective Component 17 27
Unauthorized Access to Computer System 16 16
Connection Problem 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28812 28936
Insufficient Information 1094 1194
Hyperglycemia 577 616
No Consequences Or Impact To Patient 506 506
Hypoglycemia 357 400
Rash 206 346
Itching Sensation 181 299
No Known Impact Or Consequence To Patient 126 167
Hemorrhage/Bleeding 120 159
Erythema 93 171
Skin Irritation 78 162
Pain 70 121
Caustic/Chemical Burns 64 98
Reaction 59 107
Hypersensitivity/Allergic reaction 47 77
Bruise/Contusion 44 54
Discomfort 41 55
Skin Inflammation/ Irritation 38 53
Blister 37 51
Scarring 36 55
Swelling 33 67
Hematoma 31 31
Burning Sensation 30 49
Diabetic Ketoacidosis 25 34
Fluid Discharge 21 33
Unspecified Infection 18 21
Inflammation 17 22
Loss of consciousness 17 17
Skin Burning Sensation 16 19
Scar Tissue 15 24
Purulent Discharge 14 25
Discharge 12 20
Foreign Body In Patient 12 13
Irritation 12 29
Fatigue 11 11
Swelling/ Edema 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 33
Superficial (First Degree) Burn 11 17
Skin Discoloration 11 12
Burn(s) 11 16
Impaired Healing 10 17
Urticaria 10 12
Local Reaction 9 12
Skin Inflammation 9 35
Anxiety 8 12
Nausea 8 8
Malaise 8 8
Contact Dermatitis 8 10
Hypoxia 8 8
Peeling 7 10

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 MiniMed II Jan-01-2023
8 Medtronic MiniMed, Inc. II Oct-02-2025
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