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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 3

MDR Year MDR Reports MDR Events
2021 66221 66293
2022 154932 155223
2023 145198 145244
2024 129584 129596
2025 152966 152969
2026 63433 63439

Device Problems MDRs with this Device Problem Events in those MDRs
Break 129913 129956
Power Problem 125850 125882
Obstruction of Flow 95028 95095
Material Integrity Problem 52316 52335
Adverse Event Without Identified Device or Use Problem 52075 52110
Appropriate Device Problem Term/Code Not Available 51096 51116
No Display/Image 48292 48315
Wireless Communication Problem 45761 45785
Battery Problem 42606 42634
Mechanical Problem 38816 38826
Incorrect, Inadequate or Imprecise Result or Readings 30758 30760
Moisture or Humidity Problem 27521 27526
Key or Button Unresponsive/not Working 27429 27431
Insufficient Flow or Under Infusion 19476 19488
Communication or Transmission Problem 17915 17943
Device Difficult to Program or Calibrate 16619 16625
Display or Visual Feedback Problem 15580 15583
Computer Software Problem 14885 14942
Circuit Failure 14560 14562
Unexpected Therapeutic Results 13638 13645
Fracture 11229 11230
Calibration Problem 10899 10903
Insufficient Device Problem Information 10193 10193
Device Alarm System 9144 9156
Excess Flow or Over-Infusion 8430 8431
Connection Problem 8194 8195
Electrical /Electronic Property Problem 8099 8113
Patient Device Interaction Problem 7395 7400
Loss of Data 6135 6140
Use of Device Problem 5407 5409
Unintended Movement 4674 4679
Visual Prompts will not Clear 4322 4324
Physical Resistance/Sticking 4301 4305
Priming Problem 3974 3975
No Apparent Adverse Event 3841 3848
Failure of Device to Self-Test 3307 3308
Mechanical Jam 2957 2959
No Visual Prompts/Feedback 2001 2001
Environmental Compatibility Problem 1396 1396
Intermittent Loss of Power 1392 1395
Date/Time-Related Software Problem 1113 1113
Human-Device Interface Problem 845 845
Manufacturing, Packaging or Shipping Problem 793 793
Difficult to Remove 791 792
Device Unsafe to Use in Environment 784 784
Overheating of Device 752 754
Infusion or Flow Problem 718 718
Device Markings/Labelling Problem 619 620
Material Twisted/Bent 585 585
Intermittent Communication Failure 509 509

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 530776 531036
Hyperglycemia 99596 99690
Insufficient Information 46894 46951
Hypoglycemia 36984 37012
Elevated ketones/Diabetic Ketoacidosis 7810 7822
Hemorrhage/Blood Loss/Bleeding 4134 4134
Malaise 2642 2642
Vomiting 2568 2570
Nausea 2217 2220
Fatigue 1979 1979
Loss of consciousness 1815 1815
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1710 1712
Headache 1589 1589
Confusion/ Disorientation 1492 1492
Pain 1178 1178
Polydipsia 1014 1014
Dizziness 735 736
Shaking/Tremors 707 708
Abdominal Pain 657 658
Dehydration 645 645
Diaphoresis 555 555
Dyspnea 473 473
Skin Inflammation/ Irritation 471 471
Coma 378 379
Convulsion, Clonic 368 368
Blurred Vision 333 333
Unspecified Tissue Injury 322 322
Cramp(s) /Muscle Spasm(s) 294 294
Unspecified Infection 293 293
Discomfort 284 284
Bruise/Contusion 275 275
Muscle Weakness/Atrophy 264 264
Urinary Frequency / Polyuria 246 246
Syncope/Fainting 235 235
Chest Pain 201 201
Anxiety 181 181
Respiratory Tract Infection 174 174
Scar Tissue 164 164
Myocardial Infarction 145 156
Viral Infection 144 144
Rash 124 135
Itching Sensation 124 135
Diarrhea 123 124
Hematoma 117 117
Cardiac Arrest 115 115
Renal Failure 111 111
Lethargy 109 109
Pneumonia 103 103
Swelling/ Edema 99 99
Erythema 90 90

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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