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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 99216 106695
2020 74591 74591
2021 50926 50926
2022 78114 78114
2023 24391 24391
2024 12141 12141

Device Problems MDRs with this Device Problem Events in those MDRs
Break 67265 67265
Patient Device Interaction Problem 60990 60990
Power Problem 36076 36076
Mechanical Problem 25430 32909
Device Difficult to Program or Calibrate 23072 30551
Material Integrity Problem 20609 20609
Obstruction of Flow 19035 19035
Battery Problem 16248 16248
No Display/Image 14533 14533
Connection Problem 12476 12476
Adverse Event Without Identified Device or Use Problem 12359 12359
Device Alarm System 10829 10829
Pumping Stopped 9117 9117
Moisture or Humidity Problem 7394 7394
Circuit Failure 6906 6906
No Apparent Adverse Event 6891 6891
Appropriate Term/Code Not Available 6819 6819
Display or Visual Feedback Problem 5754 5754
Charging Problem 5289 5289
Failure to Cycle 5072 5072
Incorrect Measurement 5062 5062
Detachment of Device or Device Component 4144 4144
Insufficient Flow or Under Infusion 3914 3914
Premature Discharge of Battery 3815 3815
Communication or Transmission Problem 3789 3789
Failure to Sense 3776 3776
Device Displays Incorrect Message 3522 3522
Wireless Communication Problem 3095 3095
Computer Software Problem 2989 2989
Insufficient Information 2800 2800
Visual Prompts will not Clear 2707 2707
Priming Problem 2705 2705
Structural Problem 2324 2324
Loss of Data 1952 1952
False Alarm 1851 1851
Crack 1766 1766
Electrical /Electronic Property Problem 1717 1717
Physical Resistance/Sticking 1686 1686
Failure of Device to Self-Test 1595 1595
Device Sensing Problem 1562 1562
Excess Flow or Over-Infusion 1425 1425
Filling Problem 1401 1401
Imprecision 1300 1300
Date/Time-Related Software Problem 1260 1260
Use of Device Problem 1115 1115
Unintended Movement 1050 1050
Mechanical Jam 795 795
Image Display Error/Artifact 786 786
Data Problem 725 725
Loose or Intermittent Connection 675 675

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 137689 145168
No Clinical Signs, Symptoms or Conditions 126932 126932
Insufficient Information 30725 30725
Hyperglycemia 23392 23392
No Known Impact Or Consequence To Patient 16055 16055
Hypoglycemia 6199 6199
Diabetic Ketoacidosis 2392 2392
Nausea 758 758
Vomiting 678 678
Loss of consciousness 288 288
Abdominal Pain 278 278
Death 240 240
Dyspnea 169 169
Headache 147 147
Coma 136 136
Blood Loss 118 118
Polydipsia 114 114
Complaint, Ill-Defined 110 110
Confusion/ Disorientation 102 102
Pain 95 95
Dizziness 90 90
Fatigue 87 87
Discomfort 83 83
No Patient Involvement 83 83
Unspecified Tissue Injury 83 83
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 76 76
Dehydration 72 72
Seizures 69 69
Unspecified Infection 63 63
Shaking/Tremors 49 49
Malaise 38 38
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 22 22
No Code Available 21 21
Fever 20 20
Stroke/CVA 20 20
Weakness 19 19
Urinary Frequency 19 19
Blurred Vision 18 18
Diarrhea 17 17
Lethargy 16 16
Convulsion/Seizure 16 16
Pneumonia 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
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