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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

MDR Year MDR Reports MDR Events
2021 50917 50926
2022 77938 77950
2023 24388 24465
2024 17602 17620
2025 12365 12365
2026 5705 5707

Device Problems MDRs with this Device Problem Events in those MDRs
Break 58333 58338
Power Problem 24195 24197
Material Integrity Problem 16023 16024
Mechanical Problem 13095 13096
Obstruction of Flow 12017 12026
No Display/Image 8058 8059
Battery Problem 8019 8036
Patient Device Interaction Problem 6571 6571
Device Difficult to Program or Calibrate 6167 6167
Connection Problem 4544 4544
Moisture or Humidity Problem 3864 3864
Adverse Event Without Identified Device or Use Problem 3415 3420
Display or Visual Feedback Problem 2914 2914
Key or Button Unresponsive/not Working 2687 2687
Circuit Failure 2617 2617
Appropriate Device Problem Term/Code Not Available 2617 2618
Detachment of Device or Device Component 2416 2416
Pumping Stopped 2370 2401
Failure to Cycle 2178 2179
Insufficient Flow or Under Infusion 2171 2172
Device Alarm System 1847 1847
Insufficient Device Problem Information 1746 1747
Computer Software Problem 1543 1543
Charging Problem 1538 1547
Premature Discharge of Battery 1533 1533
Visual Prompts will not Clear 1514 1514
Failure to Sense 1396 1415
Incorrect Measurement 1360 1374
Communication or Transmission Problem 1308 1308
Fracture 1256 1256
No Apparent Adverse Event 1206 1207
Loss of Data 1057 1058
Failure of Device to Self-Test 913 913
Electrical /Electronic Property Problem 891 891
Unintended Movement 784 784
Priming Problem 780 780
Excess Flow or Over-Infusion 633 633
Wireless Communication Problem 627 628
Mechanical Jam 522 522
False Alarm 499 502
Unexpected Therapeutic Results 488 488
Date/Time-Related Software Problem 488 493
Device Sensing Problem 475 479
Crack 402 404
No Visual Prompts/Feedback 355 355
Environmental Compatibility Problem 291 291
Use of Device Problem 286 286
Loose or Intermittent Connection 284 287
Filling Problem 262 263
Poor Quality Image 261 264

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 147664 147763
Insufficient Information 30235 30241
Hyperglycemia 9847 9856
Hypoglycemia 2056 2057
Elevated ketones/Diabetic Ketoacidosis 828 831
Nausea 288 288
Vomiting 261 261
No Consequences Or Impact To Patient 174 174
No Known Impact Or Consequence To Patient 126 126
Abdominal Pain 111 111
Malaise 99 99
Headache 99 99
Loss of consciousness 97 97
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 95 95
Unspecified Tissue Injury 82 82
Fatigue 79 79
Confusion/ Disorientation 78 78
Discomfort 72 72
Polydipsia 68 68
Coma 51 51
Dyspnea 48 48
Dizziness 48 48
Shaking/Tremors 41 41
Pain 40 40
Hemorrhage/Blood Loss/Bleeding 32 32
Dehydration 24 24
Convulsion/Seizure 16 17
Anxiety 16 17
Unspecified Infection 15 15
Myocardial Infarction 14 14
Muscle Weakness/Atrophy 14 14
Chest Pain 14 14
Fall 13 13
Cardiac Arrest 13 13
Bone Cement Implantation Syndrome 12 12
Syncope/Fainting 12 12
Blurred Vision 11 11
Cancer 10 10
Diaphoresis 9 9
Convulsion, Clonic 9 9
Renal Failure 9 9
Pneumonia 8 8
Stroke/CVA 8 8
Fever 8 8
Diarrhea 8 8
Skin Inflammation/ Irritation 7 7
Heart Failure/Congestive Heart Failure 7 7
Death 7 8
Bruise/Contusion 7 7
Joint Contracture 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic MiniMed II Nov-08-2022
2 Medtronic MiniMed II Jul-08-2022
3 Medtronic MiniMed, Inc. II Apr-02-2026
4 Medtronic MiniMed, Inc. II Mar-03-2025
5 Medtronic MiniMed, Inc. I Oct-03-2024
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