• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 2023 2024
15 28 21 8 6 7 7 3

MDR Year MDR Reports MDR Events
2017 3605 3605
2018 30849 30849
2019 55490 55490
2020 74029 74029
2021 66221 66221
2022 154933 154933
2023 145192 145192
2024 29402 29402

Device Problems MDRs with this Device Problem Events in those MDRs
Power Problem 102594 102594
Break 97356 97356
Adverse Event Without Identified Device or Use Problem 62906 62906
Patient Device Interaction Problem 62372 62372
No Display/Image 46242 46242
Material Integrity Problem 39590 39590
Appropriate Term/Code Not Available 38278 38278
Wireless Communication Problem 34350 34350
Obstruction of Flow 32143 32143
Mechanical Problem 28377 28377
No Apparent Adverse Event 25744 25744
Device Difficult to Program or Calibrate 24190 24190
Moisture or Humidity Problem 24126 24126
Battery Problem 20186 20186
Connection Problem 19004 19004
Communication or Transmission Problem 18987 18987
Device Alarm System 13287 13287
Circuit Failure 12844 12844
Computer Software Problem 12623 12623
Display or Visual Feedback Problem 12024 12024
Insufficient Flow or Under Infusion 9451 9451
Insufficient Information 7789 7789
Incorrect, Inadequate or Imprecise Result or Readings 6390 6390
Unexpected Therapeutic Results 6109 6109
Electrical /Electronic Property Problem 4855 4855
Excess Flow or Over-Infusion 4838 4838
Calibration Problem 4707 4707
Loss of Data 4533 4533
Physical Resistance/Sticking 4314 4314
Visual Prompts will not Clear 4305 4305
Use of Device Problem 4082 4082
Device Displays Incorrect Message 3261 3261
Unintended Movement 3232 3232
Priming Problem 2324 2324
Failure of Device to Self-Test 2198 2198
Mechanical Jam 2026 2026
Key or Button Unresponsive/not Working 2018 2018
Intermittent Loss of Power 1209 1209
Environmental Compatibility Problem 1091 1091
Device Markings/Labelling Problem 1064 1064
Device Operates Differently Than Expected 1029 1029
Date/Time-Related Software Problem 918 918
Fracture 862 862
Overheating of Device 694 694
Human-Device Interface Problem 648 648
Bent 551 551
Intermittent Communication Failure 429 429
Manufacturing, Packaging or Shipping Problem 422 422
Difficult to Remove 398 398
Incorrect Or Inadequate Test Results 346 346
Detachment Of Device Component 343 343
Device Inoperable 320 320
Crack 310 310
High Test Results 298 298
Material Twisted/Bent 269 269
Component Missing 184 184
Nonstandard Device 173 173
Failure to Deliver 162 162
Low Test Results 155 155
Packaging Problem 144 144
Inappropriate or Unexpected Reset 130 130
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 100 100
Loose or Intermittent Connection 95 95
Inaccurate Delivery 95 95
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 65 65
Unauthorized Access to Computer System 62 62
Image Display Error/Artifact 62 62
Device Slipped 62 62
Noise, Audible 61 61
Activation Problem 61 61
Detachment of Device or Device Component 60 60
Scratched Material 55 55
Failure to Read Input Signal 55 55
Device Sensing Problem 52 52
Calibration Error 52 52
Application Interface Becomes Non-Functional Or Program Exits Abnormally 46 46
Failure To Adhere Or Bond 43 43
Data Problem 43 43
Infusion or Flow Problem 42 42
Fluid/Blood Leak 42 42
Low Battery 41 41
Kinked 37 37
Application Program Problem: Dose Calculation Error 37 37
Invalid Sensing 36 36
Reset Problem 34 34
Vibration 32 32
Failure to Power Up 28 28

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 293637 293637
No Consequences Or Impact To Patient 107302 107303
Hyperglycemia 84132 84132
Insufficient Information 45645 45645
Hypoglycemia 32480 32480
Diabetic Ketoacidosis 6898 6898
Nausea 2896 2896
Vomiting 2542 2542
Blood Loss 2069 2069
Loss of consciousness 1159 1159
Fatigue 1021 1021
Headache 992 992
Abdominal Pain 989 989
Polydipsia 867 867
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 810 810
Confusion/ Disorientation 808 808
Dyspnea 735 735
Pain 701 701
Malaise 617 617
Shaking/Tremors 548 548
Dizziness 441 441
No Known Impact Or Consequence To Patient 373 373
Unspecified Tissue Injury 321 321
Coma 318 318
Skin Irritation 292 292
Diaphoresis 286 286
Bruise/Contusion 282 282
Hemorrhage/Bleeding 274 274
Discomfort 258 258
Foreign Body In Patient 254 254
Death 237 237
Dehydration 228 228
Muscle Weakness 214 214
Unspecified Infection 209 209
Blurred Vision 199 199
Complaint, Ill-Defined 193 193
Urinary Frequency 191 191
Itching Sensation 173 173
Convulsion, Clonic 169 169
Rash 162 162
Anxiety 157 157
Chest Pain 153 153
Seizures 151 151
Hematoma 114 114
Sweating 113 113
Skin Inflammation 94 94
Cramp(s) /Muscle Spasm(s) 94 94
Diarrhea 91 91
Syncope/Fainting 88 88
Skin Inflammation/ Irritation 82 82
Lethargy 81 81
Pneumonia 77 77
Cardiac Arrest 73 73
Fever 61 61
Myocardial Infarction 61 61
Renal Failure 59 59
Scar Tissue 59 59
Reaction, Injection Site 58 58
Needle Stick/Puncture 56 56
Fall 55 55
Viral Infection 51 51
High Blood Pressure/ Hypertension 50 50
Tachycardia 48 48
Urinary Tract Infection 47 47
Swelling 46 46
Erythema 46 46
Stroke/CVA 40 40
Inflammation 40 40
Irritation 39 39
Stacking Breaths 39 39
Visual Impairment 37 37
Abdominal Cramps 37 37
Hypersensitivity/Allergic reaction 36 36
Weakness 35 35
Numbness 34 34
Heart Failure/Congestive Heart Failure 33 33
Dysphagia/ Odynophagia 31 31
Bone Fracture(s) 30 30
Chills 29 29
Irritability 28 28
Skin Infection 28 28
No Code Available 26 26
Hypoglycemic Shock 26 26
Pregnancy 25 25
Cancer 22 22
Sleep Dysfunction 22 22
Purulent Discharge 22 22
Hypothermia 22 22
Swelling/ Edema 21 21
Urinary Incontinence 18 18
Burning Sensation 18 18
Skin Erosion 18 18
Dysuria 17 17
Sore Throat 16 16
Brain Injury 16 16
Shock, Insulin 16 16
Shock 16 16
Respiratory Failure 14 14
Convulsion/Seizure 14 14
Heart Failure 13 13

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 Nov-08-2022
5 Medtronic MiniMed II Jul-08-2022
6 Medtronic MiniMed II Mar-31-2022
7 Medtronic MiniMed, Inc. II Feb-07-2024
8 Medtronic Minimed II Jun-01-2021
-
-