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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
35 28 29 53 31 6

MDR Year MDR Reports MDR Events
2015 28758 28758
2016 21271 21271
2017 30438 30438
2018 39955 39955
2019 82391 82391
2020 69001 69001

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 50153 50153
Adverse Event Without Identified Device or Use Problem 29217 29217
Patient Device Interaction Problem 28527 28527
Obstruction of Flow 17406 17406
No Display/Image 16827 16827
Pumping Stopped 13731 13731
No Apparent Adverse Event 12021 12021
Mechanical Problem 10822 10822
Device Difficult to Program or Calibrate 10750 10750
Power Problem 10486 10486
Sensor 9147 9147
Battery Problem 8891 8891
Device Operates Differently Than Expected 8681 8681
Incorrect Measurement 8226 8226
Incorrect, Inadequate or Imprecise Resultor Readings 7388 7388
Break 6954 6954
Insufficient Information 6177 6177
Connection Problem 5748 5748
Cannula 5490 5490
Physical Resistance/Sticking 5347 5347
Crack 5341 5341
Charging Problem 5322 5322
Device Alarm System 5100 5100
Device Inoperable 4570 4570
Switch, Push Button 4431 4431
Bent 4375 4375
Appropriate Term/Code Not Available 4048 4048
Filling Problem 4030 4030
Failure to Sense 3829 3829
Display or Visual Feedback Problem 3765 3765
Component Missing 3708 3708
Moisture or Humidity Problem 3587 3587
Incorrect Or Inadequate Test Results 3586 3586
Failure to Deliver 3078 3078
Keypad 3069 3069
Data Problem 2791 2791
Insufficient Flow or Under Infusion 2636 2636
Priming Problem 2397 2397
Material Integrity Problem 2392 2392
False Alarm 2319 2319
Use of Device Problem 2272 2272
Screen 2267 2267
Leak/Splash 2058 2058
Reservoir 1907 1907
Visual Prompts will not Clear 1845 1845
Detachment of Device or Device Component 1811 1811
Failure to Cycle 1779 1779
Detachment Of Device Component 1644 1644
Electrode 1591 1591
Device Sensing Problem 1584 1584
Cap 1572 1572
Communication or Transmission Problem 1569 1569
Moisture Damage 1567 1567
Partial Blockage 1378 1378
Date/Time-Related Software Problem 1366 1366
Display 1349 1349
Unexpected Therapeutic Results 1327 1327
Battery 1293 1293
False Reading From Device Non-Compliance 1264 1264
Loss of Power 1255 1255
Excess Flow or Over-Infusion 1246 1246
Circuit Failure 1246 1246
Premature Discharge of Battery 1211 1211
Improper or Incorrect Procedure or Method 1195 1195
Sticking 1139 1139
Inappropriate or Unexpected Reset 1060 1060
High Test Results 1008 1008
Calibration Problem 987 987
Component Falling 984 984
Calibration Error 896 896
Noise, Audible 876 876
Motor(s) 875 875
Needle 842 842
Air Leak 838 838
Poor Quality Image 781 781
Loose or Intermittent Connection 740 740
Wireless Communication Problem 726 726
Scratched Material 725 725
Low Readings 715 715
Ring 710 710
Failure of Device to Self-Test 622 622
Application Interface Becomes Non-Functional Or Program Exits Abnormally 585 585
Fluid Leak 548 548
Low Battery 542 542
Failure to Power Up 520 520
Material Separation 516 516
Material Protrusion/Extrusion 505 505
Fitting Problem 505 505
Computer Software Problem 505 505
Loss of Threshold 483 483
Alarm, Audible 442 442
Fracture 439 439
Loss of Data 419 419
Electrical /Electronic Property Problem 416 416
Transmitter 411 411
Low Test Results 400 400
Inaccurate Delivery 387 387
Difficult to Remove 381 381
Housing 378 378
Tube 375 375

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 134372 134372
Hyperglycemia 73750 73750
No Known Impact Or Consequence To Patient 42952 42952
Hypoglycemia 22842 22842
Diabetic Ketoacidosis 5262 5262
Vomiting 1693 1693
Nausea 1600 1600
Death 890 890
Blood Loss 859 859
Loss of consciousness 784 784
Pain 464 464
Abdominal Pain 459 459
Polydipsia 365 365
Seizures 350 350
No Information 344 344
Dyspnea 341 341
Unspecified Infection 335 335
Headache 328 328
Complaint, Ill-Defined 286 286
Dehydration 263 263
Underdose 256 256
Hemorrhage/Bleeding 245 245
Coma 231 231
Fatigue 230 230
Skin Irritation 227 227
Dizziness 205 205
No Code Available 195 195
Urinary Frequency 189 189
No Patient Involvement 184 184
Foreign Body In Patient 184 184
Fall 181 181
Sweating 178 178
Overdose 163 163
Confusion/ Disorientation 135 135
Chest Pain 129 129
Bruise/Contusion 127 127
Malaise 123 123
Swelling 100 100
Shaking/Tremors 94 94
Weakness 93 93
Discomfort 81 81
Diarrhea 73 73
Itching Sensation 72 72
Myocardial Infarction 70 70
Rash 70 70
Blurred Vision 69 69
Lethargy 68 68
Pneumonia 67 67
Renal Failure 65 65
Respiratory Distress 62 62
Scar Tissue 61 61
Cardiac Arrest 56 56
Fever 54 54
Stroke/CVA 51 51
Irritation 50 50
Skin Inflammation 50 50
Tachycardia 49 49
High Blood Pressure/ Hypertension 47 47
Erythema 45 45
Urinary Tract Infection 45 45
Device Embedded In Tissue or Plaque 44 44
Bone Fracture(s) 43 43
Fainting 38 38
Syncope 36 36
Reaction, Injection Site 34 34
Cramp(s) 30 30
Congestive Heart Failure 27 27
Hypersensitivity/Allergic reaction 26 26
Anxiety 26 26
Injury 25 25
Head Injury 25 25
Purulent Discharge 24 24
Cancer 24 24
Inflammation 23 23
Ambulation Difficulties 20 20
Palpitations 20 20
Scarring 20 20
Reaction 20 20
Irritability 19 19
Needle Stick/Puncture 19 19
Burning Sensation 18 18
Shock, Insulin 17 17
Visual Impairment 16 16
Chills 16 16
Low Blood Pressure/ Hypotension 16 16
Dysphagia/ Odynophagia 16 16
Hematoma 16 16
Neuropathy 15 15
Numbness 14 14
Sleep Dysfunction 14 14
Cognitive Changes 14 14
Brain Injury 14 14
Tingling 13 13
Virus 13 13
Memory Loss/Impairment 13 13
Emotional Changes 12 12
Bacterial Infection 12 12
Heart Failure 12 12
Alteration In Body Temperature 12 12
Sepsis 11 11

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