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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 , threshold suspend
Definition An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.
Product CodeOZO
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
7 9 3 2 1 0

MDR Year MDR Reports MDR Events
2021 42577 42591
2022 54924 54952
2023 29739 29756
2024 11814 11816
2025 3653 3653
2026 868 868

Device Problems MDRs with this Device Problem Events in those MDRs
Break 29683 29686
Power Problem 14489 14492
Pumping Stopped 13884 13900
Obstruction of Flow 12611 12611
Material Integrity Problem 9112 9114
Appropriate Device Problem Term/Code Not Available 8490 8490
Adverse Event Without Identified Device or Use Problem 8472 8474
Battery Problem 8268 8269
No Display/Image 7920 7921
Charging Problem 7302 7308
Mechanical Problem 6805 6805
Failure to Sense 5693 5704
Incorrect Measurement 5495 5499
Communication or Transmission Problem 4073 4081
Device Difficult to Program or Calibrate 3816 3816
Crack 3525 3538
Connection Problem 2901 2901
Patient Device Interaction Problem 2866 2866
False Alarm 2450 2450
Moisture or Humidity Problem 1932 1932
Device Sensing Problem 1916 1917
Poor Quality Image 1856 1862
Insufficient Flow or Under Infusion 1778 1778
Filling Problem 1757 1757
Key or Button Unresponsive/not Working 1406 1406
Date/Time-Related Software Problem 1382 1383
No Apparent Adverse Event 1377 1378
Physical Resistance/Sticking 1374 1374
Device Alarm System 1288 1288
Data Problem 1267 1268
Display or Visual Feedback Problem 1256 1256
Fracture 890 890
Loose or Intermittent Connection 876 877
Priming Problem 817 817
Detachment of Device or Device Component 801 801
Excess Flow or Over-Infusion 800 801
Circuit Failure 746 746
Inappropriate or Unexpected Reset 652 652
Insufficient Device Problem Information 623 624
Leak/Splash 591 591
Unexpected Therapeutic Results 495 495
Visual Prompts will not Clear 429 429
Fitting Problem 399 399
Incorrect, Inadequate or Imprecise Result or Readings 385 385
Electrical /Electronic Property Problem 383 383
Partial Blockage 364 365
Computer Software Problem 340 340
Failure to Cycle 329 329
Use of Device Problem 294 294
Loss of Data 288 288

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 109885 109940
Insufficient Information 16355 16357
Hyperglycemia 12611 12614
Hypoglycemia 4504 4507
Elevated ketones/Diabetic Ketoacidosis 1540 1540
No Consequences Or Impact To Patient 780 780
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 749 749
Vomiting 352 352
Nausea 348 348
Loss of consciousness 291 291
No Known Impact Or Consequence To Patient 257 257
Fatigue 213 213
Confusion/ Disorientation 195 195
Headache 163 163
Unspecified Tissue Injury 150 151
Polydipsia 117 117
Malaise 116 116
Abdominal Pain 91 91
Coma 89 89
Pain 81 81
Dizziness 78 78
Dyspnea 73 73
Shaking/Tremors 62 62
Blurred Vision 54 54
Fall 51 51
Heart Failure/Congestive Heart Failure 47 47
Renal Failure 47 47
Cardiac Arrest 45 45
Myocardial Infarction 44 44
Muscle Weakness/Atrophy 42 42
Dehydration 38 38
Anxiety 37 37
Chest Pain 36 36
Convulsion/Seizure 36 36
Diaphoresis 36 36
Bruise/Contusion 35 35
Stroke/CVA 32 32
Pneumonia 30 30
Convulsion, Clonic 30 30
Unspecified Infection 29 29
Cancer 25 25
High Blood Pressure/ Hypertension 25 25
Diarrhea 24 24
Lethargy 23 23
Urinary Frequency / Polyuria 23 23
Hemorrhage/Blood Loss/Bleeding 23 23
Bone Fracture(s) 22 22
Syncope/Fainting 18 18
Cramp(s) /Muscle Spasm(s) 18 18
Urinary Retention 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic MiniMed II Jul-08-2022
2 Medtronic MiniMed, Inc. II Apr-02-2026
3 Medtronic MiniMed, Inc. II Mar-03-2025
4 Medtronic MiniMed, Inc. I Oct-03-2024
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