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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)
2018 2019 2020 2021 2022 2023
28 21 8 6 7 1

MDR Year MDR Reports MDR Events
2018 30849 30849
2019 55490 55490
2020 74029 74029
2021 66219 66219
2022 154733 154733
2023 38357 38357

Device Problems MDRs with this Device Problem Events in those MDRs
Power Problem 67264 67264
Break 67136 67136
Patient Device Interaction Problem 62200 62200
Adverse Event Without Identified Device or Use Problem 54095 54095
No Display/Image 35076 35076
Material Integrity Problem 30418 30418
No Apparent Adverse Event 25727 25727
Appropriate Term/Code Not Available 20472 20472
Wireless Communication Problem 20040 20040
Mechanical Problem 19863 19863
Obstruction of Flow 19155 19155
Device Difficult to Program or Calibrate 18279 18279
Connection Problem 18252 18252
Moisture or Humidity Problem 17371 17371
Battery Problem 14614 14614
Communication or Transmission Problem 12690 12690
Device Alarm System 11244 11244
Computer Software Problem 9458 9458
Circuit Failure 9437 9437
Display or Visual Feedback Problem 7649 7649
Incorrect, Inadequate or Imprecise Result or Readings 5693 5693
Insufficient Flow or Under Infusion 5568 5568
Physical Resistance/Sticking 4263 4263
Unexpected Therapeutic Results 3948 3948
Loss of Data 3483 3483
Electrical /Electronic Property Problem 3323 3323
Visual Prompts will not Clear 3022 3022
Excess Flow or Over-Infusion 2943 2943
Calibration Problem 2909 2909
Insufficient Information 2789 2789
Device Displays Incorrect Message 2339 2339
Unintended Movement 2260 2260
Failure of Device to Self-Test 1695 1695
Mechanical Jam 1554 1554
Priming Problem 1351 1351
Device Markings/Labelling Problem 966 966
Intermittent Loss of Power 948 948
Date/Time-Related Software Problem 744 744
Device Operates Differently Than Expected 727 727
Fracture 591 591
Environmental Compatibility Problem 572 572
Overheating of Device 507 507
Human-Device Interface Problem 423 423
Bent 367 367
Use of Device Problem 364 364
Intermittent Communication Failure 329 329
Detachment Of Device Component 295 295
Manufacturing, Packaging or Shipping Problem 283 283
Difficult to Remove 269 269
Crack 266 266
Device Inoperable 252 252
Incorrect Or Inadequate Test Results 246 246
High Test Results 244 244
Material Twisted/Bent 175 175
Nonstandard Device 169 169
Component Missing 152 152
Low Test Results 124 124
Failure to Deliver 117 117
Sticking 94 94
Air Leak 91 91
Loss of Power 80 80
Low Readings 80 80
Failure to Calibrate 79 79
Moisture Damage 77 77
Loose or Intermittent Connection 76 76
False Reading From Device Non-Compliance 73 73
Inappropriate or Unexpected Reset 72 72
Packaging Problem 63 63
Partial Blockage 61 61
Component Falling 60 60
Inaccurate Delivery 60 60
Activation Problem 57 57
Defective Component 53 53
Erratic or Intermittent Display 52 52
High Readings 51 51
Detachment of Device or Device Component 51 51
Device Slipped 50 50
Failure to Read Input Signal 47 47
Occlusion Within Device 47 47
Improper or Incorrect Procedure or Method 46 46
Device Sensing Problem 45 45
Noise, Audible 45 45
Leak/Splash 41 41
Application Interface Becomes Non-Functional Or Program Exits Abnormally 40 40
Data Problem 38 38
Infusion or Flow Problem 36 36
Image Display Error/Artifact 36 36
Scratched Material 35 35
Unauthorized Access to Computer System 34 34
Low Battery 34 34
Calibration Error 33 33
Failure To Adhere Or Bond 32 32
Fluid/Blood Leak 32 32
Application Program Problem: Dose Calculation Error 29 29
Reset Problem 29 29
Vibration 28 28
Invalid Sensing 26 26
Therapeutic or Diagnostic Output Failure 24 24
Product Quality Problem 22 22
Structural Problem 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 182971 182971
No Consequences Or Impact To Patient 106180 106181
Hyperglycemia 66333 66333
Insufficient Information 40248 40248
Hypoglycemia 25618 25618
Diabetic Ketoacidosis 5134 5134
Nausea 2219 2219
Blood Loss 2001 2001
Vomiting 1903 1903
Abdominal Pain 766 766
Loss of consciousness 669 669
Headache 612 612
Dyspnea 584 584
Pain 514 514
Polydipsia 469 469
Fatigue 421 421
Confusion/ Disorientation 382 382
Unspecified Tissue Injury 319 319
No Known Impact Or Consequence To Patient 301 301
Shaking/Tremors 281 281
Skin Irritation 270 270
Foreign Body In Patient 247 247
Dizziness 241 241
Coma 240 240
Death 232 232
Bruise/Contusion 225 225
Complaint, Ill-Defined 192 192
Discomfort 171 171
Dehydration 158 158
Seizures 149 149
Unspecified Infection 143 143
Rash 138 138
Itching Sensation 137 137
Muscle Weakness 113 113
Sweating 113 113
Chest Pain 106 106
Blurred Vision 98 98
Hematoma 92 92
Urinary Frequency 92 92
Skin Inflammation 91 91
Anxiety 86 86
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 82 82
Convulsion, Clonic 71 71
Hemorrhage/Bleeding 61 61
Pneumonia 60 60
Reaction, Injection Site 57 57
Diarrhea 52 52
Lethargy 51 51
Needle Stick/Puncture 49 49
Cardiac Arrest 47 47
Swelling 44 44
Fever 43 43
Irritation 37 37
Weakness 35 35
Inflammation 34 34
Scar Tissue 31 31
Urinary Tract Infection 30 30
Erythema 30 30
Dysphagia/ Odynophagia 30 30
Fall 30 30
Stroke/CVA 30 30
Tachycardia 27 27
Hypersensitivity/Allergic reaction 25 25
Abdominal Cramps 25 25
Pregnancy 25 25
No Code Available 23 23
High Blood Pressure/ Hypertension 22 22
Bone Fracture(s) 22 22
Visual Impairment 21 21
Cramp(s) /Muscle Spasm(s) 19 19
Diaphoresis 19 19
Dysuria 17 17
Shock, Insulin 16 16
Skin Inflammation/ Irritation 16 16
Cancer 16 16
Renal Failure 16 16
Myocardial Infarction 15 15
Chills 15 15
Purulent Discharge 15 15
Malaise 15 15
Numbness 14 14
Skin Erosion 14 14
Heart Failure 13 13
Burning Sensation 12 12
No Information 12 12
Sleep Dysfunction 12 12
Heart Failure/Congestive Heart Failure 11 11
Urinary Incontinence 11 11
Shock 11 11
Hyperemia 10 10
Unspecified Heart Problem 10 10
Device Embedded In Tissue or Plaque 10 10
Irritability 10 10
Viral Infection 9 9
Syncope/Fainting 9 9
Hypoglycemic Shock 9 9
Bacterial Infection 9 9
Cramp(s) 9 9
Brain Injury 9 9
Epistaxis 8 8

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 II Jun-01-2021
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