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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
35 37 24 31 29 40 45 52 40 79 47 14 13 8 3 4

MDR Year MDR Reports MDR Events
2014 36208 36208
2015 39943 39943
2016 97218 97218
2017 48852 48852
2018 9085 9085
2019 2124 2124
2020 912 912
2021 531 531
2022 10571 10571
2023 13869 13869
2024 3364 3364

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 79344 79344
Wireless Communication Problem 56271 56271
Device Displays Incorrect Message 55196 55196
Invalid Sensing 25600 25600
Use of Device Problem 25125 25125
No Audible Alarm 12103 12103
Communication or Transmission Problem 7477 7477
Defective Alarm 7029 7029
Imprecision 5629 5629
Battery Problem 3847 3847
Computer Software Problem 3289 3289
Inappropriate or Unexpected Reset 3155 3155
Adverse Event Without Identified Device or Use Problem 2962 2962
Component Missing 2927 2927
Detachment Of Device Component 2830 2830
Device Inoperable 2646 2646
Break 1950 1950
Display or Visual Feedback Problem 1614 1614
Appropriate Term/Code Not Available 993 993
Unable to Obtain Readings 958 958
Physical Resistance/Sticking 942 942
Incorrect, Inadequate or Imprecise Result or Readings 893 893
Crack 844 844
Structural Problem 787 787
Calibration Problem 639 639
Poor Quality Image 580 580
Unexpected Shutdown 460 460
Incorrect Or Inadequate Test Results 436 436
Detachment of Device or Device Component 391 391
No Device Output 355 355
Image Display Error/Artifact 324 324
Overheating of Device 312 312
Failure of Device to Self-Test 297 297
Patient-Device Incompatibility 281 281
Low Battery 266 266
Unexpected Therapeutic Results 265 265
Moisture Damage 258 258
Failure to Power Up 230 230
Insufficient Information 211 211
No Display/Image 192 192
Connection Problem 182 182
Fail-Safe Problem 173 173
Improper or Incorrect Procedure or Method 166 166
Bent 137 137
Failure to Prime 135 135
False Reading From Device Non-Compliance 128 128
Device Stops Intermittently 126 126
Device Alarm System 122 122
Data Problem 121 121
Sticking 112 112

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 216596 216596
No Clinical Signs, Symptoms or Conditions 26388 26388
No Known Impact Or Consequence To Patient 10956 10956
Hypoglycemia 2275 2275
Hyperglycemia 1843 1843
Insufficient Information 1083 1083
Erythema 921 921
Rash 921 921
Reaction 807 807
Itching Sensation 805 805
Loss of consciousness 539 539
Skin Irritation 519 519
Pain 259 259
Foreign Body In Patient 214 214
Injury 212 212
Death 207 207
Scarring 201 201
Diabetic Ketoacidosis 201 201
Purulent Discharge 194 194
Seizures 192 192
Unspecified Infection 171 171
Skin Inflammation 170 170
Discomfort 137 137
Swelling 117 117
No Code Available 113 113
Hemorrhage/Bleeding 98 98
Confusion/ Disorientation 96 96
Bruise/Contusion 94 94
No Information 93 93
Urticaria 83 83
Vomiting 82 82
Fluid Discharge 78 78
Burning Sensation 78 78
Blood Loss 76 76
Caustic/Chemical Burns 67 67
Burn(s) 66 66
Hypersensitivity/Allergic reaction 61 61
Irritation 60 60
Inflammation 52 52
Dizziness 50 50
Nausea 48 48
Sweating 45 45
Coma 45 45
Fainting 43 43
Skin Discoloration 41 41
Malaise 37 37
Myocardial Infarction 36 36
Hematoma 36 36
Fall 36 36
Patient Problem/Medical Problem 35 35

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. II Apr-30-2010
2 Abbott Diabetes Care, Inc. II May-20-2009
3 Dexcom Inc II Mar-25-2020
4 Dexcom Inc II Jan-31-2020
5 Dexcom Inc I Apr-11-2016
6 Medtronic Inc. II May-17-2021
7 Medtronic Inc. II Jan-11-2021
8 Medtronic Inc. II Sep-17-2020
9 Medtronic Inc. II May-22-2020
10 Medtronic Inc. II May-03-2019
11 Medtronic MiniMed II Jan-01-2023
12 Medtronic MiniMed Inc. II Aug-21-2015
13 Medtronic MiniMed Inc. II Aug-10-2014
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