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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)
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
35 28 29 53 31 8 7 9 3 2

MDR Year MDR Reports MDR Events
2015 28763 28763
2016 21282 21282
2017 30435 30435
2018 39960 46990
2019 82390 83441
2020 77812 77812
2021 42577 42577
2022 54933 54933
2023 29740 29740
2024 9920 9920

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 50994 52582
Break 39411 39411
Adverse Event Without Identified Device or Use Problem 38254 38254
Patient Device Interaction Problem 33276 33276
Obstruction of Flow 29643 29643
Pumping Stopped 28302 28302
No Display/Image 26359 26359
Power Problem 25190 25190
Mechanical Problem 17651 24144
Battery Problem 16921 16921
Device Difficult to Program or Calibrate 15098 16149
Material Integrity Problem 14191 14191
Incorrect Measurement 14125 14125
No Apparent Adverse Event 13597 13597
Charging Problem 12990 12990
Appropriate Term/Code Not Available 11889 11889
Failure to Sense 9774 9774
Crack 9086 9086
Connection Problem 8924 8924
Device Operates Differently Than Expected 8681 10269
Incorrect, Inadequate or Imprecise Result or Readings 7808 7808
Physical Resistance/Sticking 6823 6823
Insufficient Information 6768 6768
Device Alarm System 6481 6481
Filling Problem 6013 6013
Communication or Transmission Problem 5710 5710
Moisture or Humidity Problem 5468 5468
Display or Visual Feedback Problem 5034 5034
False Alarm 4939 4939
Device Inoperable 4570 4570
Bent 4375 4375
Insufficient Flow or Under Infusion 4340 4340
Data Problem 4238 4238
Component Missing 3713 3713
Incorrect Or Inadequate Test Results 3587 3587
Device Sensing Problem 3518 3518
Priming Problem 3271 3271
Failure to Deliver 3081 3081
Date/Time-Related Software Problem 2868 2868
Leak/Splash 2725 2725
Poor Quality Image 2686 2686
Use of Device Problem 2659 2659
Detachment of Device or Device Component 2635 2635
Visual Prompts will not Clear 2320 2320
Failure to Cycle 2120 2120
Circuit Failure 2078 2078
Excess Flow or Over-Infusion 2028 2028
Unexpected Therapeutic Results 1882 1882
Partial Blockage 1787 1787
Inappropriate or Unexpected Reset 1774 1774

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 140882 148963
No Clinical Signs, Symptoms or Conditions 104956 104956
Hyperglycemia 86608 86608
No Known Impact Or Consequence To Patient 44517 44517
Hypoglycemia 27493 27493
Insufficient Information 16214 16214
Diabetic Ketoacidosis 6845 6845
Vomiting 2052 2052
Nausea 1956 1956
Loss of consciousness 1083 1083
Death 907 907
Blood Loss 863 863
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 629 629
Abdominal Pain 551 551
Pain 536 536
Polydipsia 485 485
Headache 484 484
Fatigue 423 423
Dyspnea 419 419
Unspecified Infection 362 362
Seizures 355 355
No Information 345 345
Coma 331 331
Confusion/ Disorientation 318 318
Dehydration 299 299
Complaint, Ill-Defined 292 292
Dizziness 282 282
Hemorrhage/Bleeding 264 264
Underdose 257 257
Fall 233 233
Skin Irritation 227 227
Malaise 216 216
Urinary Frequency 208 208
No Code Available 195 195
Foreign Body In Patient 193 193
No Patient Involvement 189 189
Sweating 179 179
Chest Pain 166 166
Bruise/Contusion 166 166
Overdose 163 163
Shaking/Tremors 158 158
Unspecified Tissue Injury 149 149
Blurred Vision 121 121
Renal Failure 109 109
Myocardial Infarction 108 108
Swelling 101 101
Cardiac Arrest 99 99
Diarrhea 98 98
Pneumonia 97 97
Weakness 93 93

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. II Dec-02-2020
2 Medtronic Inc. I Feb-07-2020
3 Medtronic Inc. II Jul-09-2019
4 Medtronic Inc. II Dec-22-2018
5 Medtronic Inc. II Feb-21-2018
6 Medtronic MiniMed II Jul-08-2022
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