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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
2020 74588 74588
2021 50922 50922
2022 78112 78112
2023 24390 24390
2024 17601 17601
2025 2885 2885

Device Problems MDRs with this Device Problem Events in those MDRs
Break 68687 68687
Patient Device Interaction Problem 35066 35066
Power Problem 31239 31239
Material Integrity Problem 20124 20124
Mechanical Problem 17867 17867
Obstruction of Flow 13415 13415
Device Difficult to Program or Calibrate 12523 12523
Battery Problem 11784 11784
No Display/Image 10694 10694
Connection Problem 9453 9453
Adverse Event Without Identified Device or Use Problem 7103 7103
Moisture or Humidity Problem 5477 5477
Pumping Stopped 5264 5264
Circuit Failure 4161 4161
Device Alarm System 4154 4154
Display or Visual Feedback Problem 3795 3795
Failure to Cycle 3370 3370
Charging Problem 3246 3246
Detachment of Device or Device Component 3076 3076
No Apparent Adverse Event 3053 3053
Incorrect Measurement 2907 2907
Insufficient Flow or Under Infusion 2853 2853
Appropriate Term/Code Not Available 2735 2735
Failure to Sense 2587 2587
Premature Discharge of Battery 2445 2445
Communication or Transmission Problem 2296 2296
Computer Software Problem 2216 2216
Insufficient Information 2177 2177
Visual Prompts will not Clear 2050 2050
Loss of Data 1612 1612
Priming Problem 1428 1428
Key or Button Unresponsive/not Working 1410 1410
Wireless Communication Problem 1377 1377
Failure of Device to Self-Test 1217 1217
Electrical /Electronic Property Problem 1107 1107
Physical Resistance/Sticking 1086 1086
False Alarm 1080 1080
Device Displays Incorrect Message 1041 1041
Crack 998 998
Excess Flow or Over-Infusion 970 970
Device Sensing Problem 917 917
Unintended Movement 889 889
Date/Time-Related Software Problem 790 790
Filling Problem 680 680
Mechanical Jam 623 623
Use of Device Problem 589 589
Loose or Intermittent Connection 553 553
Device Markings/Labelling Problem 475 475
Unexpected Therapeutic Results 454 454
Environmental Compatibility Problem 449 449

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 134659 134659
No Consequences Or Impact To Patient 59095 59095
Insufficient Information 30728 30728
Hyperglycemia 14618 14618
No Known Impact Or Consequence To Patient 7183 7183
Hypoglycemia 3631 3631
Diabetic Ketoacidosis 1410 1410
Nausea 505 505
Vomiting 452 452
Abdominal Pain 193 193
Loss of consciousness 182 182
Headache 106 106
Dyspnea 100 100
Coma 95 95
Death 92 92
Confusion/ Disorientation 88 88
Polydipsia 88 88
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 82 82
Unspecified Tissue Injury 82 82
Discomfort 78 78
Fatigue 78 78
Dizziness 62 62
Malaise 55 55
Complaint, Ill-Defined 52 52
Dehydration 50 50
Pain 50 50
Blood Loss 48 48
Shaking/Tremors 45 45
Unspecified Infection 35 35
Fall 23 23
Bruise/Contusion 21 21
Chest Pain 21 21
Seizures 21 21
Anxiety 20 20
No Patient Involvement 19 19
Hemorrhage/Bleeding 19 19
Cardiac Arrest 18 18
Myocardial Infarction 18 18
Renal Failure 17 17
Convulsion/Seizure 16 16
Sweating 16 16
Blurred Vision 15 15
Muscle Weakness 14 14
Stroke/CVA 14 14
Weakness 14 14
Skin Irritation 13 13
Diarrhea 12 12
Fever 12 12
Convulsion, Clonic 11 11
Memory Loss/Impairment 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic MiniMed II Nov-08-2022
2 Medtronic MiniMed II Jul-08-2022
3 Medtronic MiniMed II Mar-26-2020
4 Medtronic MiniMed, Inc. II Mar-03-2025
5 Medtronic MiniMed, Inc. I Oct-03-2024
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