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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)
2019 2020 2021 2022 2023 2024
2 0 0 0 0 0

MDR Year MDR Reports MDR Events
2019 99212 106691
2020 74588 74588
2021 50925 50925
2022 78114 78114
2023 24390 24390
2024 13569 13569

Device Problems MDRs with this Device Problem Events in those MDRs
Break 67551 67551
Patient Device Interaction Problem 60990 60990
Power Problem 36429 36429
Mechanical Problem 25604 33083
Device Difficult to Program or Calibrate 23070 30549
Material Integrity Problem 20721 20721
Obstruction of Flow 19238 19238
Battery Problem 16293 16293
No Display/Image 14609 14609
Connection Problem 12485 12485
Adverse Event Without Identified Device or Use Problem 12367 12367
Device Alarm System 10837 10837
Pumping Stopped 9128 9128
Moisture or Humidity Problem 7439 7439
Circuit Failure 6934 6934
No Apparent Adverse Event 6888 6888
Appropriate Term/Code Not Available 6858 6858
Display or Visual Feedback Problem 5799 5799
Charging Problem 5291 5291
Failure to Cycle 5107 5107
Incorrect Measurement 5065 5065
Detachment of Device or Device Component 4170 4170
Insufficient Flow or Under Infusion 3925 3925
Premature Discharge of Battery 3829 3829
Communication or Transmission Problem 3791 3791
Failure to Sense 3785 3785
Device Displays Incorrect Message 3522 3522
Wireless Communication Problem 3096 3096
Computer Software Problem 2998 2998
Insufficient Information 2803 2803
Visual Prompts will not Clear 2751 2751
Priming Problem 2714 2714
Structural Problem 2324 2324
Loss of Data 1964 1964
False Alarm 1851 1851
Crack 1767 1767
Electrical /Electronic Property Problem 1722 1722
Physical Resistance/Sticking 1686 1686
Failure of Device to Self-Test 1608 1608
Device Sensing Problem 1564 1564
Excess Flow or Over-Infusion 1428 1428
Filling Problem 1401 1401
Imprecision 1300 1300
Date/Time-Related Software Problem 1268 1268
Use of Device Problem 1119 1119
Unintended Movement 1056 1056
Mechanical Jam 799 799
Image Display Error/Artifact 786 786
Data Problem 727 727
Key or Button Unresponsive/not Working 708 708

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 137686 145165
No Clinical Signs, Symptoms or Conditions 128285 128285
Insufficient Information 30727 30727
Hyperglycemia 23455 23455
No Known Impact Or Consequence To Patient 16055 16055
Hypoglycemia 6202 6202
Diabetic Ketoacidosis 2396 2396
Nausea 760 760
Vomiting 679 679
Loss of consciousness 287 287
Abdominal Pain 278 278
Death 240 240
Dyspnea 170 170
Headache 147 147
Coma 137 137
Blood Loss 118 118
Polydipsia 114 114
Complaint, Ill-Defined 110 110
Confusion/ Disorientation 103 103
Pain 94 94
Dizziness 91 91
Fatigue 89 89
Discomfort 84 84
Unspecified Tissue Injury 83 83
No Patient Involvement 83 83
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 78 78
Dehydration 72 72
Seizures 69 69
Unspecified Infection 63 63
Shaking/Tremors 49 49
Malaise 42 42
Chest Pain 35 35
Skin Irritation 32 32
Cardiac Arrest 30 30
Fall 29 29
Bruise/Contusion 29 29
Sweating 27 27
Myocardial Infarction 23 23
Anxiety 23 23
Renal Failure 23 23
No Code Available 21 21
Stroke/CVA 20 20
Fever 20 20
Weakness 19 19
Urinary Frequency 19 19
Blurred Vision 18 18
Diarrhea 18 18
Pneumonia 16 16
Lethargy 16 16
Swelling 16 16

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. I Oct-03-2024
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