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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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)
2020 2021 2022 2023 2024 2025
8 7 9 3 2 0

MDR Year MDR Reports MDR Events
2020 77812 77812
2021 42579 42579
2022 54935 54935
2023 29740 29740
2024 11813 11813
2025 506 506

Device Problems MDRs with this Device Problem Events in those MDRs
Break 33608 33608
Pumping Stopped 21431 21431
Power Problem 19028 19028
Obstruction of Flow 19009 19009
Patient Device Interaction Problem 18508 18508
Adverse Event Without Identified Device or Use Problem 16235 16235
Material Integrity Problem 12767 12767
No Display/Image 12039 12039
Battery Problem 11216 11216
Charging Problem 10518 10518
Mechanical Problem 10313 10313
Incorrect Measurement 9470 9470
Appropriate Term/Code Not Available 8503 8503
Device Displays Incorrect Message 7707 7707
Failure to Sense 7617 7617
Device Difficult to Program or Calibrate 7516 7516
Connection Problem 6159 6159
Physical Resistance/Sticking 5167 5167
No Apparent Adverse Event 4899 4899
Crack 4845 4845
Communication or Transmission Problem 4404 4404
Filling Problem 3863 3863
False Alarm 3752 3752
Moisture or Humidity Problem 2931 2931
Data Problem 2748 2748
Device Sensing Problem 2528 2528
Device Alarm System 2470 2470
Insufficient Flow or Under Infusion 2459 2459
Display or Visual Feedback Problem 2272 2272
Poor Quality Image 2206 2206
Date/Time-Related Software Problem 2143 2143
Leak/Splash 1623 1623
Priming Problem 1569 1569
Detachment of Device or Device Component 1372 1372
Circuit Failure 1348 1348
Use of Device Problem 1169 1169
Inappropriate or Unexpected Reset 1124 1124
Excess Flow or Over-Infusion 1117 1117
Loose or Intermittent Connection 1075 1075
Incorrect, Inadequate or Imprecise Result or Readings 1035 1035
Visual Prompts will not Clear 982 982
Unexpected Therapeutic Results 925 925
Insufficient Information 914 914
Partial Blockage 889 889
Key or Button Unresponsive/not Working 837 837
Failure to Cycle 736 736
Fitting Problem 668 668
Computer Software Problem 551 551
Electrical /Electronic Property Problem 550 550
Loss of Data 499 499

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 106886 106886
No Consequences Or Impact To Patient 54078 54078
Hyperglycemia 20463 20463
Insufficient Information 16440 16440
No Known Impact Or Consequence To Patient 12333 12333
Hypoglycemia 7979 7979
Diabetic Ketoacidosis 2564 2564
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 690 690
Nausea 662 662
Vomiting 632 632
Loss of consciousness 443 443
Fatigue 235 235
Abdominal Pain 220 220
Confusion/ Disorientation 206 206
Headache 200 200
Dyspnea 184 184
Unspecified Tissue Injury 150 150
Polydipsia 147 147
Coma 141 141
Death 136 136
Malaise 108 108
Dizziness 107 107
Pain 106 106
Blood Loss 86 86
Shaking/Tremors 80 80
Complaint, Ill-Defined 70 70
Fall 68 68
No Patient Involvement 68 68
Blurred Vision 67 67
Seizures 64 64
Dehydration 63 63
Bruise/Contusion 57 57
Chest Pain 56 56
Renal Failure 54 54
Myocardial Infarction 54 54
Unspecified Infection 52 52
Cardiac Arrest 47 47
Pneumonia 42 42
Heart Failure/Congestive Heart Failure 41 41
Muscle Weakness 40 40
Stroke/CVA 40 40
Diarrhea 38 38
Foreign Body In Patient 37 37
Convulsion/Seizure 36 36
Anxiety 35 35
Diaphoresis 35 35
High Blood Pressure/ Hypertension 34 34
Urinary Frequency 33 33
Convulsion, Clonic 29 29
Bone Fracture(s) 28 28

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. II Dec-02-2020
2 Medtronic Inc. I Feb-07-2020
3 Medtronic MiniMed II Jul-08-2022
4 Medtronic MiniMed, Inc. I Oct-03-2024
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