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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, infusion, insulin, to be used with invasive glucose sensor
Definition The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.
Product CodeOYC
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 1 1 17 13 9 2 0 0 0 0 0

MDR Year MDR Reports MDR Events
2014 64905 64905
2015 105273 105273
2016 96914 96914
2017 132641 138181
2018 106242 119564
2019 99216 106695
2020 74591 74591
2021 50926 50926
2022 78114 78114
2023 24391 24391
2024 12141 12141

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 206674 216345
Break 84701 84701
Patient Device Interaction Problem 70644 70644
No Display/Image 42468 42468
Power Problem 40255 40255
Device Operates Differently Than Expected 37854 47525
Adverse Event Without Identified Device or Use Problem 36395 36395
Mechanical Problem 30918 43837
Battery Problem 25599 25599
Device Difficult to Program or Calibrate 24944 36174
Device Inoperable 23773 23773
Structural Problem 23342 23342
Obstruction of Flow 22246 22246
Material Integrity Problem 20957 20957
Device Alarm System 20650 20650
Crack 18913 18913
Pumping Stopped 18605 18605
Insufficient Information 15373 15373
Moisture or Humidity Problem 14900 14900
Connection Problem 14011 14011
Moisture Damage 13232 13232
Wireless Communication Problem 11494 11494
Failure to Deliver 11088 11088
Appropriate Term/Code Not Available 10747 10747
Incorrect Measurement 10660 10660
Image Display Error/Artifact 10155 10155
Charging Problem 9180 9180
No Apparent Adverse Event 8836 8836
Circuit Failure 8492 8492
Display or Visual Feedback Problem 7167 7167
Premature Discharge of Battery 6940 6940
Bent 6373 6373
Visual Prompts will not Clear 6228 6228
Failure to Cycle 6187 6187
Communication or Transmission Problem 5736 5736
Electrical /Electronic Property Problem 5495 5495
Improper or Incorrect Procedure or Method 5359 5359
Insufficient Flow or Under Infusion 5286 5286
Detachment of Device or Device Component 5264 5264
Failure to Sense 5191 5191
Material Protrusion/Extrusion 5060 5060
Component Missing 4703 4703
Sticking 4547 4547
Fail-Safe Problem 4429 4429
Loose or Intermittent Connection 4345 4345
Failure to Prime 4088 4088
Component Falling 4048 4048
Use of Device Problem 3845 3845
Detachment Of Device Component 3807 3807
Loss of Power 3792 3792

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 286100 312442
Hyperglycemia 206400 206400
No Known Impact Or Consequence To Patient 161107 161107
No Clinical Signs, Symptoms or Conditions 127020 127020
Hypoglycemia 35515 35515
Insufficient Information 30731 30731
Diabetic Ketoacidosis 11573 11573
Vomiting 4149 4149
Nausea 3741 3741
No Information 2882 2882
Death 1844 1844
Loss of consciousness 1744 1744
Polydipsia 1620 1620
Underdose 1254 1254
Headache 963 963
Abdominal Pain 893 893
Unspecified Infection 814 814
Overdose 785 785
Dehydration 760 760
Dizziness 759 759
Fall 755 755
Fatigue 746 746
Complaint, Ill-Defined 732 732
No Code Available 717 717
Urinary Frequency 710 710
Pain 707 707
Dyspnea 648 648
Sweating 629 629
Seizures 591 591
Coma 573 573
Confusion/ Disorientation 562 563
Malaise 442 442
Chest Pain 409 409
No Patient Involvement 367 367
Blood Loss 314 314
Myocardial Infarction 310 310
Weakness 308 308
Shaking/Tremors 299 299
Lethargy 284 284
Hemorrhage/Bleeding 253 253
Blurred Vision 249 249
Stroke/CVA 227 227
Cardiac Arrest 220 220
Pneumonia 217 217
Renal Failure 215 215
Diarrhea 198 198
Urinary Tract Infection 163 163
Swelling 153 153
Respiratory Distress 147 147
Discomfort 142 142

Recalls
Manufacturer Recall Class Date Posted
1 Animas Corporation II Jan-30-2015
2 Medtronic MiniMed II Nov-08-2022
3 Medtronic MiniMed II Jul-08-2022
4 Medtronic MiniMed II Mar-26-2020
5 Medtronic MiniMed II Apr-10-2013
6 Medtronic MiniMed Inc. II Dec-17-2015
7 Medtronic MiniMed Inc. II Aug-22-2014
8 Tandem Diabetes Care Inc II Jul-18-2018
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