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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)
2016 2017 2018 2019 2020 2021
7 15 28 21 8 5

MDR Year MDR Reports MDR Events
2016 63 63
2017 3605 3605
2018 30839 30839
2019 55489 55489
2020 74029 74029
2021 52693 52693

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 58045 58045
Adverse Event Without Identified Device or Use Problem 42375 42375
No Apparent Adverse Event 23762 23762
Power Problem 23631 23631
Break 17918 17918
No Display/Image 16786 16786
Connection Problem 15499 15499
Device Difficult to Program or Calibrate 11637 11637
Mechanical Problem 11280 11280
Moisture or Humidity Problem 10506 10506
Appropriate Term/Code Not Available 10421 10421
Device Alarm System 9646 9646
Obstruction of Flow 6994 6994
Circuit Failure 5402 5402
Incorrect, Inadequate or Imprecise Resultor Readings 5366 5366
Display or Visual Feedback Problem 4485 4485
Battery Problem 3539 3539
Device Displays Incorrect Message 3287 3287
Computer Software Problem 3260 3260
Communication or Transmission Problem 3099 3099
Material Integrity Problem 3006 3006
Insufficient Flow or Under Infusion 2934 2934
Unexpected Therapeutic Results 2788 2788
Insufficient Information 2487 2487
Calibration Problem 1915 1915
Excess Flow or Over-Infusion 1788 1788
Visual Prompts will not Clear 1657 1657
Electrical /Electronic Property Problem 1312 1312
Loss of Data 1081 1081
Failure of Device to Self-Test 1046 1046
Device Operates Differently Than Expected 1036 1036
Mechanical Jam 947 947
Priming Problem 868 868
Unintended Movement 721 721
Bent 552 552
Device Markings/Labelling Problem 521 521
Date/Time-Related Software Problem 470 470
Physical Resistance/Sticking 453 453
Fracture 442 442
Intermittent Loss of Power 431 431
Incorrect Or Inadequate Test Results 346 346
Detachment Of Device Component 344 344
Device Inoperable 325 325
High Test Results 298 298
Crack 286 286
Overheating of Device 269 269
Difficult to Remove 219 219
Environmental Compatibility Problem 201 201
Component Missing 180 180
Intermittent Communication Failure 166 166
Failure to Deliver 160 160
Low Test Results 156 156
Manufacturing, Packaging or Shipping Problem 146 146
Human-Device Interface Problem 140 140
Air Leak 126 126
Sticking 124 124
Material Twisted/Bent 123 123
Loss of Power 119 119
False Reading From Device Non-Compliance 114 114
Low Readings 111 111
Moisture Damage 108 108
Failure to Calibrate 93 93
Loose or Intermittent Connection 92 92
Partial Blockage 91 91
Inaccurate Delivery 91 91
Use of Device Problem 87 87
Component Falling 87 87
High Readings 85 85
Wireless Communication Problem 77 77
Occlusion Within Device 75 75
Improper or Incorrect Procedure or Method 73 73
Erratic or Intermittent Display 69 69
Leak/Splash 69 69
Image Display Error/Artifact 62 62
Device Slipped 61 61
Noise, Audible 61 61
Defective Component 59 59
Failure to Read Input Signal 55 55
Scratched Material 55 55
Detachment of Device or Device Component 53 53
Calibration Error 52 52
Application Interface Becomes Non-Functional Or Program Exits Abnormally 49 49
Device Sensing Problem 48 48
Failure To Adhere Or Bond 43 43
Low Battery 41 41
Inappropriate or Unexpected Reset 40 40
Infusion or Flow Problem 40 40
Activation Problem 37 37
Kinked 37 37
Invalid Sensing 36 36
Reset Problem 34 34
Fluid Leak 33 33
Vibration 32 32
Structural Problem 28 28
Failure to Power Up 26 26
Poor Quality Image 25 25
Physical Property Issue 24 24
Positioning Problem 22 22
Data Problem 22 22
Retraction Problem 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 107296 107297
Hyperglycemia 48940 48940
Insufficient Information 27849 27849
Hypoglycemia 20259 20259
No Clinical Signs, Symptoms or Conditions 13601 13601
Diabetic Ketoacidosis 3680 3680
Blood Loss 2069 2069
Nausea 1554 1554
Vomiting 1334 1334
Abdominal Pain 583 583
Loss of consciousness 477 477
Dyspnea 460 460
No Known Impact Or Consequence To Patient 410 410
Pain 390 390
Headache 307 307
Skin Irritation 292 292
Foreign Body In Patient 241 241
Death 237 237
Polydipsia 210 210
Bruise/Contusion 200 200
Fatigue 195 195
Complaint, Ill-Defined 193 193
Coma 183 183
Seizures 151 151
Itching Sensation 134 134
Rash 130 130
Shaking/Tremors 126 126
Discomfort 121 121
Confusion/ Disorientation 118 118
Dizziness 118 118
Unspecified Infection 115 115
Sweating 113 113
Skin Inflammation 94 94
Dehydration 92 92
Hematoma 73 73
Chest Pain 66 66
Reaction, Injection Site 58 58
Urinary Frequency 51 51
Swelling 46 46
Anxiety 45 45
Pneumonia 43 43
Irritation 39 39
Blurred Vision 38 38
Needle Stick/Puncture 38 38
Weakness 35 35
Diarrhea 30 30
Erythema 30 30
Inflammation 29 29
Fever 29 29
No Code Available 26 26
Pregnancy 25 25
Hypersensitivity/Allergic reaction 24 24
Urinary Tract Infection 24 24
Cardiac Arrest 23 23
Lethargy 23 23
Stroke/CVA 22 22
Muscle Weakness 22 22
Scar Tissue 20 20
Dysphagia/ Odynophagia 20 20
Hemorrhage/Bleeding 20 20
Unspecified Tissue Injury 18 18
Fall 17 17
Tachycardia 16 16
Shock, Insulin 16 16
Convulsion, Clonic 16 16
Dysuria 14 14
Heart Failure 13 13
Purulent Discharge 13 13
High Blood Pressure/ Hypertension 12 12
Abdominal Cramps 11 11
No Information 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Hyperemia 9 9
Bone Fracture(s) 9 9
Cramp(s) 9 9
Visual Impairment 9 9
Skin Erosion 9 9
Renal Failure 8 8
Shock 8 8
Device Embedded In Tissue or Plaque 8 8
Irritability 7 7
Numbness 7 7
Sore Throat 7 7
Scarring 7 7
Myocardial Infarction 7 7
Chills 7 7
Gastritis 7 7
Burn(s) 6 6
Burning Sensation 6 6
Brain Injury 6 6
Viral Infection 6 6
Overdose 6 6
Depression 6 6
Sleep Dysfunction 6 6
Diaphoresis 5 5
Sjogren's Syndrome 5 5
Sepsis 5 5
Vertigo 5 5
Bacterial Infection 5 5
Hyperbilirubinemia 4 4

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 Jun-01-2021
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