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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)
2019 2020 2021 2022 2023 2024
21 8 6 7 7 2

MDR Year MDR Reports MDR Events
2019 55490 55490
2020 74029 74029
2021 66221 66221
2022 154933 154933
2023 145192 145192
2024 10381 10381

Device Problems MDRs with this Device Problem Events in those MDRs
Power Problem 97139 97139
Break 93023 93023
Patient Device Interaction Problem 59816 59816
Adverse Event Without Identified Device or Use Problem 53241 53241
No Display/Image 42413 42413
Material Integrity Problem 38315 38315
Appropriate Term/Code Not Available 32604 32604
Wireless Communication Problem 32517 32517
Obstruction of Flow 29636 29636
Mechanical Problem 26878 26878
Device Difficult to Program or Calibrate 23378 23378
Moisture or Humidity Problem 23359 23359
No Apparent Adverse Event 21808 21808
Battery Problem 19268 19268
Connection Problem 18181 18181
Communication or Transmission Problem 17998 17998
Computer Software Problem 11878 11878
Circuit Failure 11835 11835
Device Alarm System 11602 11602
Display or Visual Feedback Problem 10985 10985
Insufficient Flow or Under Infusion 8421 8421
Insufficient Information 6019 6019
Unexpected Therapeutic Results 5361 5361
Incorrect, Inadequate or Imprecise Result or Readings 5239 5239
Electrical /Electronic Property Problem 4574 4574
Loss of Data 4327 4327
Physical Resistance/Sticking 4313 4313
Excess Flow or Over-Infusion 4220 4220
Visual Prompts will not Clear 4024 4024
Calibration Problem 4015 4015
Use of Device Problem 3199 3199
Unintended Movement 3046 3046
Priming Problem 2134 2134
Failure of Device to Self-Test 2063 2063
Mechanical Jam 1845 1845
Intermittent Loss of Power 1129 1129
Device Markings/Labelling Problem 1039 1039
Environmental Compatibility Problem 1014 1014
Key or Button Unresponsive/not Working 875 875
Date/Time-Related Software Problem 865 865
Fracture 761 761
Overheating of Device 635 635
Human-Device Interface Problem 487 487
Intermittent Communication Failure 400 400
Manufacturing, Packaging or Shipping Problem 391 391
Difficult to Remove 332 332
Material Twisted/Bent 231 231
Nonstandard Device 168 168
Packaging Problem 125 125
Inappropriate or Unexpected Reset 116 116
Activation Problem 58 58
Unauthorized Access to Computer System 56 56
Crack 52 52
Data Problem 40 40
Application Program Problem: Dose Calculation Error 34 34
Therapeutic or Diagnostic Output Failure 24 24
Product Quality Problem 23 23
Fluid/Blood Leak 15 15
Inaccurate Delivery 14 14
Detachment of Device or Device Component 14 14
Defective Device 13 13
Device Displays Incorrect Message 13 13
Failure to Calibrate 13 13
Failure to Deliver 10 10
Application Program Problem: Medication Error 10 10
Defective Component 9 9
Component Missing 9 9
Failure to Cycle 9 9
Protective Measures Problem 8 8
Loose or Intermittent Connection 7 7
Premature Discharge of Battery 6 6
Inadequacy of Device Shape and/or Size 6 6
Device Sensing Problem 6 6
Improper Flow or Infusion 5 5
Inadequate User Interface 5 5
Output Problem 5 5
Expulsion 5 5
Operating System Becomes Nonfunctional 4 4
Pumping Problem 4 4
Infusion or Flow Problem 4 4
Moisture Damage 4 4
Delivered as Unsterile Product 4 4
Unexpected Shutdown 4 4
Device Fell 4 4
Program or Algorithm Execution Problem 3 3
Loss of Power 3 3
Pumping Stopped 3 3
Vibration 3 3
No Flow 3 3
Problem with Software Installation 3 3
Naturally Worn 3 3
No Fail-Safe Mechanism 2 2
Medical Gas Supply Problem 2 2
Battery Problem: Low Impedance 2 2
Environmental Particulates 2 2
Device Dislodged or Dislocated 2 2
Failure to Auto Stop 2 2
Free or Unrestricted Flow 2 2
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 278517 278517
No Consequences Or Impact To Patient 92182 92182
Hyperglycemia 67852 67852
Insufficient Information 45315 45315
Hypoglycemia 24944 24944
Diabetic Ketoacidosis 6164 6164
Nausea 2806 2806
Vomiting 2420 2420
Blood Loss 1299 1299
Loss of consciousness 1016 1016
Abdominal Pain 968 968
Fatigue 963 963
Headache 946 946
Polydipsia 819 819
Confusion/ Disorientation 761 761
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 741 741
Dyspnea 719 719
Pain 538 538
Shaking/Tremors 530 530
Malaise 500 500
Dizziness 410 410
Unspecified Tissue Injury 321 321
Coma 269 269
Diaphoresis 268 268
Foreign Body In Patient 230 230
Bruise/Contusion 227 227
Discomfort 213 213
Dehydration 211 211
Muscle Weakness 209 209
Complaint, Ill-Defined 188 188
Urinary Frequency 181 181
Blurred Vision 180 180
Death 177 177
Unspecified Infection 162 162
No Known Impact Or Consequence To Patient 160 160
Hemorrhage/Bleeding 158 158
Anxiety 148 148
Convulsion, Clonic 146 146
Chest Pain 146 146
Seizures 131 131
Skin Irritation 125 125
Sweating 110 110
Itching Sensation 108 108
Hematoma 108 108
Rash 99 99
Diarrhea 85 85
Cramp(s) /Muscle Spasm(s) 84 84
Syncope/Fainting 80 80
Lethargy 79 79
Skin Inflammation/ Irritation 75 75
Pneumonia 70 70
Cardiac Arrest 64 64
Fever 56 56
Myocardial Infarction 54 54
Renal Failure 52 52
Scar Tissue 50 50
High Blood Pressure/ Hypertension 48 48
Fall 48 48
Skin Inflammation 48 48
Needle Stick/Puncture 47 47
Tachycardia 46 46
Urinary Tract Infection 42 42
Stroke/CVA 39 39
Reaction, Injection Site 39 39
Stacking Breaths 37 37
Erythema 36 36
Visual Impairment 35 35
Abdominal Cramps 34 34
Weakness 34 34
Numbness 33 33
Viral Infection 32 32
Inflammation 32 32
Dysphagia/ Odynophagia 31 31
Hypersensitivity/Allergic reaction 30 30
Bone Fracture(s) 29 29
Heart Failure/Congestive Heart Failure 29 29
Swelling 28 28
Chills 27 27
Irritability 27 27
Skin Infection 25 25
Hypoglycemic Shock 25 25
Pregnancy 25 25
Irritation 25 25
Cancer 21 21
Sleep Dysfunction 21 21
Hypothermia 20 20
Swelling/ Edema 19 19
No Code Available 17 17
Dysuria 17 17
Purulent Discharge 17 17
Urinary Incontinence 16 16
Brain Injury 16 16
Shock 15 15
Burning Sensation 15 15
Skin Erosion 14 14
Shock, Insulin 14 14
Convulsion/Seizure 13 13
Sore Throat 12 12
Memory Loss/Impairment 12 12
Hot Flashes/Flushes 11 11

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
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