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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device automated insulin dosing device system, single hormonal control
Definition An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.
Product CodeOZP
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
8 6 7 7 7 9

MDR Year MDR Reports MDR Events
2020 74042 74073
2021 66221 66235
2022 154932 154964
2023 145197 145206
2024 129584 129592
2025 129771 129771

Device Problems MDRs with this Device Problem Events in those MDRs
Power Problem 132497 132497
Break 130109 130119
Obstruction of Flow 75952 75952
Adverse Event Without Identified Device or Use Problem 57961 57972
No Display/Image 52256 52256
Material Integrity Problem 52135 52135
Appropriate Term/Code Not Available 50432 50432
Patient Device Interaction Problem 43363 43363
Wireless Communication Problem 42906 42906
Mechanical Problem 38533 38533
Battery Problem 35874 35875
Moisture or Humidity Problem 29712 29712
Incorrect, Inadequate or Imprecise Result or Readings 26056 26078
Device Difficult to Program or Calibrate 20602 20602
Communication or Transmission Problem 18700 18700
Key or Button Unresponsive/not Working 18676 18677
Insufficient Flow or Under Infusion 16968 16968
Display or Visual Feedback Problem 15459 15461
Connection Problem 15361 15361
Circuit Failure 15007 15007
Computer Software Problem 14664 14666
No Apparent Adverse Event 12039 12039
Unexpected Therapeutic Results 11950 11950
Device Alarm System 10368 10370
Calibration Problem 9719 9723
Insufficient Information 9650 9650
Excess Flow or Over-Infusion 7631 7635
Electrical /Electronic Property Problem 7288 7288
Fracture 7157 7157
Loss of Data 5734 5739
Use of Device Problem 5206 5208
Visual Prompts will not Clear 4862 4862
Unintended Movement 4393 4393
Physical Resistance/Sticking 4314 4314
Priming Problem 3709 3709
Failure of Device to Self-Test 3205 3205
Mechanical Jam 2743 2743
Environmental Compatibility Problem 1484 1484
Intermittent Loss of Power 1407 1407
No Visual Prompts/Feedback 1147 1147
Date/Time-Related Software Problem 1073 1073
Device Markings/Labelling Problem 957 957
Overheating of Device 829 829
Human-Device Interface Problem 778 778
Manufacturing, Packaging or Shipping Problem 728 728
Difficult to Remove 716 716
Material Twisted/Bent 562 562
Intermittent Communication Failure 511 511
Device Unsafe to Use in Environment 444 444
Infusion or Flow Problem 388 388

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 468081 468092
Hyperglycemia 95112 95143
No Consequences Or Impact To Patient 55459 55459
Insufficient Information 47266 47272
Hypoglycemia 35707 35736
Diabetic Ketoacidosis 8099 8101
Hemorrhage/Bleeding 3062 3062
Vomiting 2843 2844
Nausea 2678 2679
Malaise 2058 2058
Loss of consciousness 1735 1735
Fatigue 1726 1726
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1514 1515
Headache 1469 1469
Confusion/ Disorientation 1335 1335
Polydipsia 1041 1041
Pain 999 1006
Abdominal Pain 843 843
Shaking/Tremors 697 697
Dizziness 683 685
Dyspnea 626 626
Dehydration 514 514
Diaphoresis 475 475
Blood Loss 466 466
Coma 383 383
Skin Inflammation/ Irritation 330 330
Unspecified Tissue Injury 321 321
Blurred Vision 305 305
Convulsion, Clonic 305 305
Bruise/Contusion 290 290
Discomfort 281 281
Unspecified Infection 266 266
Muscle Weakness 258 258
Urinary Frequency 237 237
Cramp(s) /Muscle Spasm(s) 233 233
Syncope/Fainting 194 194
Chest Pain 194 194
Anxiety 178 178
Scar Tissue 137 137
Myocardial Infarction 133 144
Hematoma 131 131
Rash 125 136
Foreign Body In Patient 125 125
Diarrhea 121 121
Death 120 120
Respiratory Tract Infection 119 119
Itching Sensation 118 129
Viral Infection 116 116
No Known Impact Or Consequence To Patient 116 121
Complaint, Ill-Defined 114 114

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. II Dec-02-2020
2 Medtronic Inc. I Feb-07-2020
3 Medtronic MiniMed II Nov-08-2022
4 Medtronic MiniMed II Jul-08-2022
5 Medtronic MiniMed II Mar-31-2022
6 Medtronic MiniMed, Inc. II Mar-03-2025
7 Medtronic MiniMed, Inc. I Oct-03-2024
8 Medtronic MiniMed, Inc. II Feb-07-2024
9 Medtronic Minimed II Jun-01-2021
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