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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 42580 42580
2022 54935 54935
2023 29740 29740
2024 11813 11813
2025 2037 2037

Device Problems MDRs with this Device Problem Events in those MDRs
Break 33981 33981
Pumping Stopped 21565 21565
Obstruction of Flow 19307 19307
Power Problem 19098 19098
Patient Device Interaction Problem 18511 18511
Adverse Event Without Identified Device or Use Problem 16311 16311
Material Integrity Problem 12906 12906
No Display/Image 12128 12128
Battery Problem 11399 11399
Charging Problem 10577 10577
Mechanical Problem 10412 10412
Incorrect Measurement 9497 9497
Appropriate Term/Code Not Available 8616 8616
Device Displays Incorrect Message 7707 7707
Failure to Sense 7645 7645
Device Difficult to Program or Calibrate 7516 7516
Connection Problem 6167 6167
Physical Resistance/Sticking 5168 5168
No Apparent Adverse Event 4899 4899
Crack 4866 4866
Communication or Transmission Problem 4429 4429
Filling Problem 3874 3874
False Alarm 3769 3769
Moisture or Humidity Problem 2951 2951
Data Problem 2753 2753
Device Sensing Problem 2558 2558
Insufficient Flow or Under Infusion 2487 2487
Device Alarm System 2484 2484
Display or Visual Feedback Problem 2296 2296
Poor Quality Image 2228 2228
Date/Time-Related Software Problem 2148 2148
Leak/Splash 1626 1626
Priming Problem 1585 1585
Detachment of Device or Device Component 1381 1381
Circuit Failure 1351 1351
Use of Device Problem 1174 1174
Excess Flow or Over-Infusion 1128 1128
Inappropriate or Unexpected Reset 1126 1126
Loose or Intermittent Connection 1076 1076
Incorrect, Inadequate or Imprecise Result or Readings 1036 1036
Visual Prompts will not Clear 982 982
Key or Button Unresponsive/not Working 966 966
Unexpected Therapeutic Results 928 928
Insufficient Information 927 927
Partial Blockage 890 890
Failure to Cycle 741 741
Fitting Problem 668 668
Computer Software Problem 558 558
Electrical /Electronic Property Problem 556 556
Wireless Communication Problem 501 501

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 108140 108140
No Consequences Or Impact To Patient 54078 54078
Hyperglycemia 20591 20591
Insufficient Information 16544 16544
No Known Impact Or Consequence To Patient 12333 12333
Hypoglycemia 8014 8014
Diabetic Ketoacidosis 2583 2583
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 717 717
Nausea 662 662
Vomiting 634 634
Loss of consciousness 444 444
Fatigue 237 237
Abdominal Pain 220 220
Confusion/ Disorientation 208 208
Headache 201 201
Dyspnea 184 184
Unspecified Tissue Injury 150 150
Polydipsia 147 147
Coma 141 141
Death 136 136
Malaise 112 112
Dizziness 109 109
Pain 108 108
Blood Loss 86 86
Shaking/Tremors 80 80
Complaint, Ill-Defined 70 70
Blurred Vision 68 68
Fall 68 68
No Patient Involvement 68 68
Dehydration 65 65
Seizures 64 64
Bruise/Contusion 58 58
Myocardial Infarction 56 56
Renal Failure 56 56
Chest Pain 56 56
Unspecified Infection 52 52
Cardiac Arrest 47 47
Heart Failure/Congestive Heart Failure 44 44
Pneumonia 43 43
Stroke/CVA 40 40
Muscle Weakness 40 40
Diarrhea 38 38
Foreign Body In Patient 37 37
Convulsion/Seizure 36 36
Anxiety 35 35
High Blood Pressure/ Hypertension 35 35
Diaphoresis 35 35
Urinary Frequency 34 34
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. II Mar-03-2025
5 Medtronic MiniMed, Inc. I Oct-03-2024
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