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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 3476 3477

Device Problems MDRs with this Device Problem Events in those MDRs
Break 71064 71069
Power Problem 24905 24907
Material Integrity Problem 21343 21344
Mechanical Problem 13000 13001
Obstruction of Flow 11775 11783
No Display/Image 8587 8588
Battery Problem 8573 8590
Patient Device Interaction Problem 6740 6740
Device Difficult to Program or Calibrate 6215 6215
Connection Problem 4570 4570
Moisture or Humidity Problem 3887 3887
Adverse Event Without Identified Device or Use Problem 3434 3439
Display or Visual Feedback Problem 2846 2846
Circuit Failure 2656 2656
Appropriate Term/Code Not Available 2625 2626
Key or Button Unresponsive/not Working 2506 2506
Detachment of Device or Device Component 2396 2396
Pumping Stopped 2368 2399
Insufficient Flow or Under Infusion 2165 2166
Failure to Cycle 2160 2161
Device Alarm System 1965 1965
Insufficient Information 1746 1747
Computer Software Problem 1654 1654
Charging Problem 1541 1550
Premature Discharge of Battery 1526 1526
Visual Prompts will not Clear 1519 1519
Communication or Transmission Problem 1513 1513
Failure to Sense 1397 1416
Incorrect Measurement 1361 1375
No Apparent Adverse Event 1207 1208
Fracture 1104 1104
Loss of Data 1093 1094
Electrical /Electronic Property Problem 908 908
Failure of Device to Self-Test 899 899
Unintended Movement 806 806
Priming Problem 768 768
Excess Flow or Over-Infusion 629 629
Wireless Communication Problem 627 628
Mechanical Jam 519 519
False Alarm 503 506
Date/Time-Related Software Problem 499 504
Unexpected Therapeutic Results 497 497
Device Sensing Problem 476 480
Crack 418 420
Device Markings/Labelling Problem 330 330
Environmental Compatibility Problem 301 301
No Visual Prompts/Feedback 300 300
Use of Device Problem 293 293
Loose or Intermittent Connection 286 289
Filling Problem 263 264

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 145591 145689
Insufficient Information 30234 30240
Hyperglycemia 9716 9725
Hypoglycemia 2029 2030
Diabetic Ketoacidosis 819 822
Nausea 285 285
Vomiting 255 255
No Consequences Or Impact To Patient 174 174
No Known Impact Or Consequence To Patient 126 126
Abdominal Pain 111 111
Headache 97 97
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 95 95
Loss of consciousness 95 95
Malaise 92 92
Unspecified Tissue Injury 82 82
Confusion/ Disorientation 77 77
Fatigue 75 75
Discomfort 72 72
Polydipsia 68 68
Coma 51 51
Dyspnea 48 48
Dizziness 47 47
Shaking/Tremors 41 41
Pain 39 39
Hemorrhage/Bleeding 32 32
Dehydration 24 24
Convulsion/Seizure 16 17
Anxiety 16 17
Unspecified Infection 15 15
Myocardial Infarction 14 14
Muscle Weakness 14 14
Chest Pain 13 13
Fall 13 13
Cardiac Arrest 13 13
Syncope/Fainting 12 12
Blurred Vision 11 11
Cancer 10 10
Diaphoresis 9 9
Convulsion, Clonic 9 9
Renal Failure 9 9
Diarrhea 8 8
Fever 8 8
Stroke/CVA 8 8
Pneumonia 8 8
Death 7 8
Heart Failure/Congestive Heart Failure 7 7
Bruise/Contusion 7 7
Abdominal Cramps 6 6
Urinary Tract Infection 6 6
Skin Inflammation/ Irritation 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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