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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)
2021 2022 2023 2024 2025 2026
6 7 7 7 14 1

MDR Year MDR Reports MDR Events
2021 66221 66293
2022 154932 155223
2023 145197 145243
2024 129584 129596
2025 152966 152969
2026 36904 36904

Device Problems MDRs with this Device Problem Events in those MDRs
Break 137687 137731
Power Problem 125287 125321
Obstruction of Flow 88635 88698
Material Integrity Problem 57461 57481
Appropriate Term/Code Not Available 50451 50469
Adverse Event Without Identified Device or Use Problem 50319 50362
No Display/Image 49996 50020
Wireless Communication Problem 45010 45034
Battery Problem 40262 40291
Mechanical Problem 37576 37586
Incorrect, Inadequate or Imprecise Result or Readings 29116 29131
Moisture or Humidity Problem 27055 27060
Key or Button Unresponsive/not Working 24640 24642
Insufficient Flow or Under Infusion 18295 18306
Communication or Transmission Problem 18006 18035
Device Difficult to Program or Calibrate 16691 16697
Display or Visual Feedback Problem 15097 15100
Computer Software Problem 14653 14713
Circuit Failure 14146 14148
Unexpected Therapeutic Results 13090 13097
Calibration Problem 10539 10547
Fracture 10066 10066
Insufficient Information 9859 9859
Device Alarm System 8870 8884
Connection Problem 8070 8071
Excess Flow or Over-Infusion 7992 7996
Electrical /Electronic Property Problem 7767 7785
Patient Device Interaction Problem 7628 7633
Loss of Data 5905 5910
Use of Device Problem 5358 5362
Unintended Movement 4524 4529
Visual Prompts will not Clear 4331 4333
Physical Resistance/Sticking 4314 4318
No Apparent Adverse Event 3859 3866
Priming Problem 3824 3825
Failure of Device to Self-Test 3150 3151
Mechanical Jam 2807 2809
No Visual Prompts/Feedback 1750 1750
Environmental Compatibility Problem 1394 1394
Intermittent Loss of Power 1366 1369
Date/Time-Related Software Problem 1075 1075
Human-Device Interface Problem 819 819
Overheating of Device 785 787
Manufacturing, Packaging or Shipping Problem 754 754
Difficult to Remove 753 754
Device Markings/Labelling Problem 728 729
Device Unsafe to Use in Environment 687 687
Infusion or Flow Problem 592 592
Material Twisted/Bent 572 572
Intermittent Communication Failure 496 496

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 511096 511351
Hyperglycemia 94350 94443
Insufficient Information 46862 46919
Hypoglycemia 35292 35320
Diabetic Ketoacidosis 7519 7531
Hemorrhage/Bleeding 3869 3869
Vomiting 2471 2473
Malaise 2460 2460
Nausea 2174 2177
Fatigue 1876 1876
Loss of consciousness 1743 1743
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1641 1643
Headache 1521 1521
Confusion/ Disorientation 1439 1439
Pain 1106 1106
Polydipsia 994 994
Dizziness 706 707
Shaking/Tremors 688 689
Abdominal Pain 635 636
Dehydration 595 595
Diaphoresis 539 539
Dyspnea 462 462
Skin Inflammation/ Irritation 436 436
Coma 364 365
Convulsion, Clonic 355 355
Unspecified Tissue Injury 322 322
Blurred Vision 313 313
Unspecified Infection 281 281
Discomfort 276 276
Cramp(s) /Muscle Spasm(s) 269 269
Muscle Weakness 264 264
Bruise/Contusion 262 262
Urinary Frequency 238 238
Syncope/Fainting 224 224
Chest Pain 188 188
Anxiety 171 171
Respiratory Tract Infection 165 165
Scar Tissue 157 157
Myocardial Infarction 137 148
Viral Infection 132 132
Rash 118 129
Itching Sensation 117 128
Diarrhea 116 117
Hematoma 114 114
Cardiac Arrest 111 111
Renal Failure 110 110
Lethargy 109 109
Pneumonia 97 97
Swelling/ Edema 91 91
Hypoglycemic Shock 87 87

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-31-2022
4 Medtronic MiniMed, Inc. II Apr-02-2026
5 Medtronic MiniMed, Inc. II Feb-02-2026
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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