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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 device system, single hormonal control
Definition An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.
Product CodeOZP
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
15 28 21 8 6 3

MDR Year MDR Reports MDR Events
2017 3605 3605
2018 30849 30849
2019 55490 55490
2020 74029 74029
2021 66215 66215
2022 81747 81747

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 61682 61682
Adverse Event Without Identified Device or Use Problem 49972 49972
Break 43608 43608
Power Problem 42310 42310
No Display/Image 25975 25975
No Apparent Adverse Event 25391 25391
Connection Problem 17630 17630
Mechanical Problem 15757 15757
Device Difficult to Program or Calibrate 15279 15279
Material Integrity Problem 14110 14110
Obstruction of Flow 13868 13868
Moisture or Humidity Problem 13750 13750
Appropriate Term/Code Not Available 12976 12976
Device Alarm System 10577 10577
Battery Problem 7635 7635
Circuit Failure 7478 7478
Communication or Transmission Problem 6770 6770
Computer Software Problem 6748 6748
Display or Visual Feedback Problem 5817 5817
Incorrect, Inadequate or Imprecise Resultor Readings 5442 5442
Insufficient Flow or Under Infusion 4127 4127
Unexpected Therapeutic Results 3420 3420
Device Displays Incorrect Message 3261 3261
Insufficient Information 2708 2708
Electrical /Electronic Property Problem 2494 2494
Wireless Communication Problem 2477 2477
Excess Flow or Over-Infusion 2330 2330
Visual Prompts will not Clear 2305 2305
Calibration Problem 2139 2139
Loss of Data 2031 2031
Unintended Movement 1653 1653
Mechanical Jam 1286 1286
Failure of Device to Self-Test 1284 1284
Physical Resistance/Sticking 1200 1200
Priming Problem 1131 1131
Device Operates Differently Than Expected 1029 1029
Device Markings/Labelling Problem 708 708
Intermittent Loss of Power 649 649
Date/Time-Related Software Problem 611 611
Bent 551 551
Fracture 493 493
Overheating of Device 371 371
Environmental Compatibility Problem 349 349
Incorrect Or Inadequate Test Results 346 346
Detachment Of Device Component 343 343
Human-Device Interface Problem 342 342
Device Inoperable 320 320
High Test Results 298 298
Crack 298 298
Intermittent Communication Failure 247 247
Difficult to Remove 233 233
Manufacturing, Packaging or Shipping Problem 202 202
Component Missing 183 183
Failure to Deliver 161 161
Low Test Results 155 155
Use of Device Problem 155 155
Material Twisted/Bent 139 139
Air Leak 126 126
Sticking 122 122
Loss of Power 118 118
False Reading From Device Non-Compliance 114 114
Low Readings 111 111
Moisture Damage 107 107
Failure to Calibrate 96 96
Inaccurate Delivery 94 94
Loose or Intermittent Connection 94 94
Partial Blockage 91 91
High Readings 87 87
Component Falling 86 86
Occlusion Within Device 74 74
Improper or Incorrect Procedure or Method 73 73
Erratic or Intermittent Display 71 71
Leak/Splash 69 69
Defective Component 64 64
Device Slipped 62 62
Image Display Error/Artifact 62 62
Noise, Audible 61 61
Detachment of Device or Device Component 57 57
Scratched Material 55 55
Failure to Read Input Signal 55 55
Calibration Error 52 52
Device Sensing Problem 50 50
Inappropriate or Unexpected Reset 48 48
Application Interface Becomes Non-Functional Or Program Exits Abnormally 46 46
Failure To Adhere Or Bond 43 43
Low Battery 41 41
Infusion or Flow Problem 41 41
Activation Problem 37 37
Kinked 37 37
Invalid Sensing 36 36
Fluid Leak 35 35
Reset Problem 34 34
Nonstandard Device 32 32
Vibration 32 32
Failure to Power Up 27 27
Structural Problem 27 27
Data Problem 26 26
Therapeutic or Diagnostic Output Failure 24 24
Physical Property Issue 24 24
Poor Quality Image 24 24

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 107302 107303
No Clinical Signs, Symptoms or Conditions 82177 82177
Hyperglycemia 59509 59509
Insufficient Information 40229 40229
Hypoglycemia 23669 23669
Diabetic Ketoacidosis 4435 4435
Blood Loss 2069 2069
Nausea 1920 1920
Vomiting 1658 1658
Abdominal Pain 688 688
Loss of consciousness 560 560
Dyspnea 539 539
Pain 467 467
Headache 455 455
No Known Impact Or Consequence To Patient 373 373
Polydipsia 355 355
Fatigue 331 331
Unspecified Tissue Injury 318 318
Skin Irritation 292 292
Confusion/ Disorientation 261 261
Foreign Body In Patient 246 246
Death 237 237
Bruise/Contusion 221 221
Shaking/Tremors 215 215
Coma 212 212
Complaint, Ill-Defined 193 193
Dizziness 175 175
Seizures 151 151
Discomfort 146 146
Itching Sensation 142 142
Dehydration 139 139
Rash 138 138
Unspecified Infection 127 127
Sweating 113 113
Skin Inflammation 94 94
Chest Pain 87 87
Muscle Weakness 86 86
Hematoma 83 83
Urinary Frequency 73 73
Anxiety 71 71
Blurred Vision 70 70
Reaction, Injection Site 58 58
Pneumonia 52 52
Hemorrhage/Bleeding 49 49
Swelling 46 46
Needle Stick/Puncture 44 44
Diarrhea 40 40
Irritation 39 39
Inflammation 37 37
Fever 37 37
Lethargy 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Cardiac Arrest 35 35
Weakness 35 35
Convulsion, Clonic 31 31
Erythema 30 30
Urinary Tract Infection 28 28
Dysphagia/ Odynophagia 27 27
Fall 26 26
Stroke/CVA 26 26
No Code Available 26 26
Pregnancy 25 25
Hypersensitivity/Allergic reaction 25 25
Scar Tissue 25 25
Tachycardia 21 21
High Blood Pressure/ Hypertension 18 18
Abdominal Cramps 18 18
Dysuria 16 16
Shock, Insulin 16 16
Visual Impairment 15 15
Purulent Discharge 14 14
Cancer 14 14
Heart Failure 13 13
Skin Erosion 13 13
Renal Failure 13 13
No Information 12 12
Numbness 12 12
Myocardial Infarction 11 11
Bone Fracture(s) 11 11
Shock 10 10
Chills 10 10
Diaphoresis 10 10
Device Embedded In Tissue or Plaque 10 10
Unspecified Heart Problem 10 10
Sleep Dysfunction 9 9
Cramp(s) 9 9
Burning Sensation 9 9
Hyperemia 9 9
Viral Infection 8 8
Sore Throat 8 8
Heart Failure/Congestive Heart Failure 8 8
Depression 7 7
Irritability 7 7
Scarring 7 7
Gastritis 7 7
Burn(s) 6 6
Sepsis 6 6
Overdose 6 6
Brain Injury 6 6
Vertigo 6 6

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 MiniMed II Jul-08-2022
5 Medtronic MiniMed II Mar-31-2022
6 Medtronic Minimed II Jun-01-2021
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