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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 902 902

Device Problems MDRs with this Device Problem Events in those MDRs
Break 70492 70497
Power Problem 24685 24687
Material Integrity Problem 20949 20950
Mechanical Problem 12833 12834
Obstruction of Flow 11201 11209
No Display/Image 8432 8432
Battery Problem 8376 8393
Patient Device Interaction Problem 6738 6738
Device Difficult to Program or Calibrate 6215 6215
Connection Problem 4561 4561
Moisture or Humidity Problem 3864 3864
Adverse Event Without Identified Device or Use Problem 3427 3432
Display or Visual Feedback Problem 2766 2766
Appropriate Term/Code Not Available 2617 2618
Circuit Failure 2614 2614
Pumping Stopped 2361 2392
Detachment of Device or Device Component 2351 2351
Key or Button Unresponsive/not Working 2315 2315
Insufficient Flow or Under Infusion 2139 2140
Failure to Cycle 2128 2129
Device Alarm System 1956 1956
Insufficient Information 1729 1730
Computer Software Problem 1641 1641
Charging Problem 1540 1549
Visual Prompts will not Clear 1519 1519
Premature Discharge of Battery 1518 1518
Communication or Transmission Problem 1509 1509
Failure to Sense 1397 1416
Incorrect Measurement 1360 1374
No Apparent Adverse Event 1207 1208
Loss of Data 1082 1083
Fracture 904 904
Failure of Device to Self-Test 889 889
Electrical /Electronic Property Problem 887 887
Unintended Movement 792 792
Priming Problem 753 753
Wireless Communication Problem 623 624
Excess Flow or Over-Infusion 616 616
Mechanical Jam 505 505
False Alarm 502 505
Date/Time-Related Software Problem 493 498
Unexpected Therapeutic Results 489 489
Device Sensing Problem 476 480
Crack 418 420
Device Markings/Labelling Problem 330 330
Environmental Compatibility Problem 301 301
Use of Device Problem 290 290
Loose or Intermittent Connection 286 289
Filling Problem 263 264
Poor Quality Image 262 265

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 143204 143301
Insufficient Information 30233 30239
Hyperglycemia 9543 9552
Hypoglycemia 2013 2014
Diabetic Ketoacidosis 805 808
Nausea 284 284
Vomiting 249 249
No Consequences Or Impact To Patient 174 174
No Known Impact Or Consequence To Patient 126 126
Abdominal Pain 107 107
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 95 95
Loss of consciousness 92 92
Headache 89 89
Malaise 87 87
Unspecified Tissue Injury 82 82
Confusion/ Disorientation 76 76
Discomfort 71 71
Fatigue 69 69
Polydipsia 68 68
Coma 51 51
Dyspnea 47 47
Dizziness 47 47
Shaking/Tremors 41 41
Pain 38 38
Hemorrhage/Bleeding 29 29
Dehydration 21 21
Anxiety 16 17
Convulsion/Seizure 16 17
Unspecified Infection 15 15
Myocardial Infarction 14 14
Muscle Weakness 14 14
Fall 13 13
Chest Pain 13 13
Cardiac Arrest 13 13
Syncope/Fainting 11 11
Blurred Vision 11 11
Convulsion, Clonic 9 9
Cancer 9 9
Diaphoresis 9 9
Renal Failure 9 9
Diarrhea 8 8
Pneumonia 8 8
Stroke/CVA 8 8
Bruise/Contusion 7 7
Death 7 8
Fever 7 7
Heart Failure/Congestive Heart Failure 7 7
Abdominal Cramps 6 6
Joint Contracture 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 Mar-03-2025
4 Medtronic MiniMed, Inc. I Oct-03-2024
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