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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 0

MDR Year MDR Reports MDR Events
2020 74039 74039
2021 66222 66222
2022 154934 154934
2023 145192 145192
2024 129593 129601
2025 12568 12568

Device Problems MDRs with this Device Problem Events in those MDRs
Power Problem 125668 125669
Break 113583 113584
Obstruction of Flow 52748 52750
Adverse Event Without Identified Device or Use Problem 49672 49674
Appropriate Term/Code Not Available 47827 47829
No Display/Image 46272 46272
Material Integrity Problem 44594 44594
Patient Device Interaction Problem 43266 43266
Wireless Communication Problem 39069 39070
Mechanical Problem 32399 32399
Moisture or Humidity Problem 25825 25825
Battery Problem 24743 24743
Device Difficult to Program or Calibrate 20561 20561
Communication or Transmission Problem 18234 18234
Connection Problem 14788 14788
Computer Software Problem 13235 13235
Display or Visual Feedback Problem 12931 12931
Circuit Failure 12856 12856
Insufficient Flow or Under Infusion 12550 12551
No Apparent Adverse Event 12039 12039
Key or Button Unresponsive/not Working 9722 9722
Device Alarm System 8899 8899
Insufficient Information 8470 8470
Incorrect, Inadequate or Imprecise Result or Readings 8442 8442
Unexpected Therapeutic Results 7733 7733
Electrical /Electronic Property Problem 5796 5796
Excess Flow or Over-Infusion 5762 5762
Calibration Problem 5321 5321
Loss of Data 5020 5020
Use of Device Problem 4873 4873
Visual Prompts will not Clear 4861 4861
Physical Resistance/Sticking 4314 4314
Unintended Movement 3753 3753
Priming Problem 2936 2936
Failure of Device to Self-Test 2479 2479
Mechanical Jam 2206 2206
Environmental Compatibility Problem 1469 1469
Intermittent Loss of Power 1228 1228
Fracture 1111 1111
Device Markings/Labelling Problem 944 944
Date/Time-Related Software Problem 909 909
Overheating of Device 721 721
Human-Device Interface Problem 674 674
Manufacturing, Packaging or Shipping Problem 495 495
Difficult to Remove 488 488
Intermittent Communication Failure 443 443
Material Twisted/Bent 304 304
Packaging Problem 235 235
Nonstandard Device 168 168
Inappropriate or Unexpected Reset 133 133

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 381197 381202
Hyperglycemia 74456 74457
No Consequences Or Impact To Patient 55459 55459
Insufficient Information 46996 46996
Hypoglycemia 26794 26796
Diabetic Ketoacidosis 6610 6610
Nausea 2471 2471
Vomiting 2402 2402
Fatigue 1290 1290
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1288 1288
Loss of consciousness 1280 1280
Malaise 1251 1251
Hemorrhage/Bleeding 1200 1200
Headache 1144 1144
Confusion/ Disorientation 1037 1037
Polydipsia 948 948
Abdominal Pain 798 798
Pain 705 705
Shaking/Tremors 596 596
Dyspnea 582 582
Dizziness 517 517
Blood Loss 465 465
Diaphoresis 350 350
Unspecified Tissue Injury 321 321
Coma 318 318
Dehydration 292 292
Discomfort 250 250
Blurred Vision 247 247
Muscle Weakness 246 246
Bruise/Contusion 238 238
Convulsion, Clonic 237 237
Urinary Frequency 202 202
Skin Inflammation/ Irritation 198 198
Unspecified Infection 179 179
Anxiety 165 165
Chest Pain 164 164
Cramp(s) /Muscle Spasm(s) 158 158
Syncope/Fainting 135 135
Foreign Body In Patient 122 122
Death 120 120
No Known Impact Or Consequence To Patient 115 115
Complaint, Ill-Defined 114 114
Hematoma 110 110
Diarrhea 98 98
Myocardial Infarction 98 98
Rash 97 97
Lethargy 93 93
Scar Tissue 92 92
Cardiac Arrest 88 88
Viral Infection 87 87

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. I Oct-03-2024
7 Medtronic MiniMed, Inc. II Feb-07-2024
8 Medtronic Minimed II Jun-01-2021
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