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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 2

MDR Year MDR Reports MDR Events
2020 74039 74039
2021 66222 66222
2022 154934 154934
2023 145198 145198
2024 129590 129590
2025 67582 67582

Device Problems MDRs with this Device Problem Events in those MDRs
Power Problem 128440 128440
Break 121450 121450
Obstruction of Flow 63739 63739
Adverse Event Without Identified Device or Use Problem 53567 53567
Appropriate Term/Code Not Available 49665 49665
No Display/Image 48965 48965
Material Integrity Problem 48233 48233
Patient Device Interaction Problem 43326 43326
Wireless Communication Problem 40726 40726
Mechanical Problem 35113 35113
Battery Problem 30404 30404
Moisture or Humidity Problem 27029 27029
Device Difficult to Program or Calibrate 20576 20576
Communication or Transmission Problem 18476 18476
Incorrect, Inadequate or Imprecise Result or Readings 16149 16149
Connection Problem 15069 15069
Insufficient Flow or Under Infusion 14810 14810
Circuit Failure 13946 13946
Display or Visual Feedback Problem 13944 13944
Computer Software Problem 13929 13929
Key or Button Unresponsive/not Working 13799 13799
No Apparent Adverse Event 12039 12039
Unexpected Therapeutic Results 9731 9731
Device Alarm System 9595 9595
Insufficient Information 8959 8959
Calibration Problem 7232 7232
Excess Flow or Over-Infusion 6822 6822
Electrical /Electronic Property Problem 6479 6479
Loss of Data 5359 5359
Use of Device Problem 5017 5017
Visual Prompts will not Clear 4862 4862
Physical Resistance/Sticking 4314 4314
Fracture 4169 4169
Unintended Movement 4082 4082
Priming Problem 3348 3348
Failure of Device to Self-Test 2777 2777
Mechanical Jam 2438 2438
Environmental Compatibility Problem 1474 1474
Intermittent Loss of Power 1309 1309
Date/Time-Related Software Problem 990 990
Device Markings/Labelling Problem 953 953
Overheating of Device 777 777
Human-Device Interface Problem 734 734
Manufacturing, Packaging or Shipping Problem 611 611
Difficult to Remove 603 603
No Visual Prompts/Feedback 490 490
Intermittent Communication Failure 477 477
Material Twisted/Bent 406 406
Packaging Problem 275 275
Device Unsafe to Use in Environment 255 255

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 422062 422062
Hyperglycemia 84260 84260
No Consequences Or Impact To Patient 55459 55459
Insufficient Information 47204 47204
Hypoglycemia 30722 30722
Diabetic Ketoacidosis 7329 7329
Vomiting 2607 2607
Nausea 2567 2567
Hemorrhage/Bleeding 2055 2055
Malaise 1632 1632
Loss of consciousness 1504 1504
Fatigue 1486 1486
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1394 1394
Headache 1280 1280
Confusion/ Disorientation 1178 1178
Polydipsia 1007 1007
Pain 848 848
Abdominal Pain 822 822
Shaking/Tremors 639 639
Dyspnea 597 597
Dizziness 592 592
Blood Loss 465 465
Diaphoresis 391 391
Dehydration 387 387
Coma 346 346
Unspecified Tissue Injury 321 321
Blurred Vision 277 277
Skin Inflammation/ Irritation 270 270
Convulsion, Clonic 268 268
Discomfort 268 268
Bruise/Contusion 267 267
Muscle Weakness 249 249
Unspecified Infection 224 224
Urinary Frequency 211 211
Cramp(s) /Muscle Spasm(s) 193 193
Chest Pain 182 182
Anxiety 172 172
Syncope/Fainting 170 170
Foreign Body In Patient 124 124
Death 120 120
Hematoma 119 119
No Known Impact Or Consequence To Patient 115 115
Rash 114 114
Complaint, Ill-Defined 114 114
Myocardial Infarction 112 112
Scar Tissue 111 111
Viral Infection 108 108
Diarrhea 108 108
Itching Sensation 104 104
Lethargy 103 103

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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