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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 , threshold suspend
Definition An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.
Product CodeOZO
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
53 31 8 7 9 2

MDR Year MDR Reports MDR Events
2018 39960 46990
2019 82390 83441
2020 77812 77812
2021 42586 42586
2022 54977 54977
2023 14490 14490

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 33252 33252
Adverse Event Without Identified Device or Use Problem 30642 30642
Break 28853 28853
Obstruction of Flow 26521 26521
Pumping Stopped 25466 25466
Device Displays Incorrect Message 23270 24858
Power Problem 21734 21734
No Display/Image 18296 18296
Mechanical Problem 16039 22532
Device Difficult to Program or Calibrate 14503 15554
No Apparent Adverse Event 13594 13594
Battery Problem 13476 13476
Material Integrity Problem 13439 13439
Incorrect Measurement 12878 12878
Charging Problem 11480 11480
Connection Problem 8469 8469
Failure to Sense 8209 8209
Appropriate Term/Code Not Available 7437 7437
Physical Resistance/Sticking 6825 6825
Crack 6163 6163
Filling Problem 5720 5720
Device Alarm System 4912 4912
Display or Visual Feedback Problem 4675 4675
Communication or Transmission Problem 4626 4626
False Alarm 4464 4464
Incorrect, Inadequate or Imprecise Result or Readings 4190 4190
Moisture or Humidity Problem 4059 4059
Data Problem 4006 4006
Insufficient Flow or Under Infusion 3655 3655
Priming Problem 3030 3030
Device Sensing Problem 2605 2605
Date/Time-Related Software Problem 2400 2400
Use of Device Problem 2345 2345
Detachment of Device or Device Component 2342 2342
Leak/Splash 2296 2296
Failure to Cycle 2079 2079
Circuit Failure 2013 2013
Visual Prompts will not Clear 1915 1915
Poor Quality Image 1882 1882
Unexpected Therapeutic Results 1846 1846
Insufficient Information 1802 1802
Partial Blockage 1650 1650
Inappropriate or Unexpected Reset 1482 1482
Excess Flow or Over-Infusion 1423 1423
Premature Discharge of Battery 1146 1146
Device Operates Differently Than Expected 1047 2635
Loose or Intermittent Connection 944 944
Wireless Communication Problem 919 919
Computer Software Problem 810 810
Calibration Problem 780 780
Electrical /Electronic Property Problem 764 764
Component Missing 758 758
Fitting Problem 755 755
Loss of Data 675 675
Incorrect Or Inadequate Test Results 581 581
Failure of Device to Self-Test 551 551
Material Separation 499 499
Mechanical Jam 488 488
Device Inoperable 449 449
Fracture 430 430
Unintended Movement 416 416
Detachment Of Device Component 411 411
Bent 388 388
Failure to Deliver 386 386
Material Twisted/Bent 378 378
Temperature Problem 360 360
High Test Results 329 329
Device Markings/Labelling Problem 328 328
Human-Device Interface Problem 321 321
Failure to Power Up 247 247
Overheating of Device 241 241
Failure to Auto Stop 238 238
Loss of Power 234 234
Intermittent Communication Failure 209 209
Environmental Compatibility Problem 173 173
Improper Flow or Infusion 169 169
Material Frayed 169 169
Nonstandard Device 149 149
Moisture Damage 141 141
Noise, Audible 128 128
Material Deformation 120 120
Manufacturing, Packaging or Shipping Problem 115 115
Component Falling 113 113
Activation Problem 111 111
Air Leak 110 110
Difficult to Remove 109 109
Sticking 108 108
Material Protrusion/Extrusion 107 107
Low Battery 106 106
Scratched Material 101 101
Fluid/Blood Leak 97 97
False Reading From Device Non-Compliance 93 93
Disconnection 88 88
Unexpected Shutdown 80 80
Device Fell 80 80
Low Test Results 80 80
Low Readings 79 79
Difficult to Insert 78 78
Device Slipped 77 77
Failure to Read Input Signal 73 73

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 129934 138015
No Clinical Signs, Symptoms or Conditions 84521 84521
Hyperglycemia 43594 43594
No Known Impact Or Consequence To Patient 26160 26160
Hypoglycemia 15272 15272
Insufficient Information 13822 13822
Diabetic Ketoacidosis 4122 4122
Nausea 1052 1052
Vomiting 993 993
Blood Loss 634 634
Loss of consciousness 575 575
Death 441 441
Abdominal Pain 355 355
Dyspnea 286 286
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 231 231
Headache 230 230
Pain 221 221
Coma 212 212
Fatigue 200 200
No Patient Involvement 182 182
Confusion/ Disorientation 180 180
Foreign Body In Patient 163 163
Unspecified Tissue Injury 149 149
Polydipsia 146 146
Dizziness 139 139
Seizures 137 137
Complaint, Ill-Defined 121 121
Unspecified Infection 102 102
Dehydration 100 100
Skin Irritation 99 99
Bruise/Contusion 98 98
Shaking/Tremors 79 79
Chest Pain 75 75
Fall 74 74
Blurred Vision 69 69
Diarrhea 51 51
Myocardial Infarction 48 48
Renal Failure 48 48
Pneumonia 48 48
Sweating 48 48
Cardiac Arrest 47 47
Discomfort 46 46
Skin Inflammation 43 43
Rash 43 43
Malaise 40 40
Urinary Frequency 39 39
Weakness 38 38
Swelling 36 36
Bone Fracture(s) 35 35
Muscle Weakness 34 34
Itching Sensation 34 34
Convulsion/Seizure 33 33
High Blood Pressure/ Hypertension 31 31
Stroke/CVA 30 30
Anxiety 27 27
Reaction, Injection Site 25 25
Lethargy 25 25
Cancer 23 23
Inflammation 23 23
Fever 22 22
Needle Stick/Puncture 21 21
Heart Failure/Congestive Heart Failure 20 20
Urinary Tract Infection 20 20
Urinary Retention 19 19
Hematoma 19 19
Convulsion, Clonic 18 18
Visual Impairment 16 16
Tachycardia 16 16
Dysphagia/ Odynophagia 16 16
Scar Tissue 15 15
No Code Available 14 14
Fainting 13 13
Head Injury 12 12
Hemorrhage/Bleeding 12 12
Irritation 12 12
Diaphoresis 12 12
Unspecified Heart Problem 12 12
Shock, Insulin 11 11
Hypersensitivity/Allergic reaction 11 11
Erythema 11 11
Memory Loss/Impairment 10 10
Sepsis 10 10
Abdominal Cramps 10 10
Numbness 9 9
Syncope/Fainting 9 9
Hyperemia 9 9
Congestive Heart Failure 9 9
Purulent Discharge 8 8
Foreign Body Reaction 8 8
Scarring 8 8
Brain Injury 8 8
Cramp(s) /Muscle Spasm(s) 8 8
Dysuria 8 8
Laceration(s) 7 7
Bronchitis 7 7
Low Blood Pressure/ Hypotension 7 7
Burn(s) 7 7
Abrasion 7 7
Liver Damage/Dysfunction 6 6
Neuropathy 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 Inc. II Dec-22-2018
5 Medtronic Inc. II Feb-21-2018
6 Medtronic MiniMed II Jul-08-2022
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