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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)
2017 2018 2019 2020 2021 2022
29 53 31 8 7 4

MDR Year MDR Reports MDR Events
2017 30435 30435
2018 39957 46987
2019 82390 83441
2020 77812 77812
2021 42583 42583
2022 14021 14021

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 34059 35647
Patient Device Interaction Problem 31423 31423
Adverse Event Without Identified Device or Use Problem 31119 31119
Obstruction of Flow 22716 22716
Pumping Stopped 21446 21446
No Display/Image 16930 16930
Break 15742 15742
Power Problem 14295 14295
Mechanical Problem 14153 20646
Device Difficult to Program or Calibrate 13296 14347
No Apparent Adverse Event 13227 13227
Incorrect Measurement 11320 11320
Battery Problem 11319 11319
Charging Problem 9640 9640
Connection Problem 7972 7972
Failure to Sense 6354 6354
Physical Resistance/Sticking 6207 6207
Crack 6073 6073
Incorrect, Inadequate or Imprecise Resultor Readings 5400 5400
Filling Problem 5378 5378
Device Alarm System 5053 5053
Appropriate Term/Code Not Available 4603 4603
Display or Visual Feedback Problem 4363 4363
Material Integrity Problem 4178 4178
False Alarm 3836 3836
Data Problem 3755 3755
Moisture or Humidity Problem 3710 3710
Device Operates Differently Than Expected 3624 5212
Communication or Transmission Problem 3515 3515
Insufficient Information 3304 3304
Insufficient Flow or Under Infusion 3263 3263
Priming Problem 2831 2831
Leak/Splash 2339 2339
Use of Device Problem 2321 2321
Detachment of Device or Device Component 2122 2122
Date/Time-Related Software Problem 2097 2097
Failure to Cycle 1988 1988
Device Sensing Problem 1932 1932
Component Missing 1915 1915
Visual Prompts will not Clear 1879 1879
Circuit Failure 1844 1844
Unexpected Therapeutic Results 1680 1680
Partial Blockage 1653 1653
Bent 1637 1637
Incorrect Or Inadequate Test Results 1596 1596
Inappropriate or Unexpected Reset 1436 1436
Excess Flow or Over-Infusion 1387 1387
Device Inoperable 1374 1374
Poor Quality Image 1334 1334
Failure to Deliver 1280 1280
Premature Discharge of Battery 1190 1190
Detachment Of Device Component 982 982
Calibration Problem 843 843
Loose or Intermittent Connection 814 814
Wireless Communication Problem 801 801
Moisture Damage 749 749
Computer Software Problem 695 695
Loss of Power 692 692
Fitting Problem 640 640
High Test Results 631 631
Failure of Device to Self-Test 618 618
Electrical /Electronic Property Problem 614 614
Loss of Data 562 562
Material Separation 489 489
Component Falling 463 463
False Reading From Device Non-Compliance 462 462
Fracture 456 456
Noise, Audible 429 429
Mechanical Jam 422 422
Sticking 382 382
Material Protrusion/Extrusion 376 376
Material Twisted/Bent 362 362
Failure to Power Up 352 352
Air Leak 345 345
Low Battery 342 342
Scratched Material 334 334
Fluid Leak 333 333
Calibration Error 315 315
Temperature Problem 297 297
Unintended Movement 271 271
Low Readings 267 267
Improper or Incorrect Procedure or Method 264 264
Human-Device Interface Problem 244 244
Application Interface Becomes Non-Functional Or Program Exits Abnormally 235 235
Failure to Auto Stop 226 226
Device Markings/Labelling Problem 224 224
Improper Flow or Infusion 221 221
Failure to Read Input Signal 213 213
High Readings 204 204
Intermittent Communication Failure 202 202
Device Slipped 199 199
Invalid Sensing 197 197
Material Deformation 189 189
Inaccurate Delivery 182 182
Overheating of Device 182 182
Low Test Results 168 168
Difficult to Remove 166 166
Failure to Prime 162 162
Material Frayed 162 162
Vibration 159 159

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 140822 148903
Hyperglycemia 53218 53218
No Clinical Signs, Symptoms or Conditions 34913 34913
No Known Impact Or Consequence To Patient 29069 29069
Hypoglycemia 17751 17751
Insufficient Information 12477 12477
Diabetic Ketoacidosis 4148 4148
Nausea 1073 1073
Vomiting 1011 1011
Blood Loss 829 829
Death 578 578
Loss of consciousness 505 505
Abdominal Pain 357 357
Dyspnea 274 274
Pain 269 269
Coma 215 215
Headache 196 196
No Patient Involvement 182 182
Foreign Body In Patient 177 177
Seizures 168 168
Skin Irritation 160 160
Fatigue 152 152
Unspecified Tissue Injury 148 148
Unspecified Infection 136 136
Complaint, Ill-Defined 135 135
Polydipsia 126 126
Bruise/Contusion 123 123
Dizziness 121 121
Confusion/ Disorientation 114 114
Dehydration 108 108
Fall 75 75
Chest Pain 71 71
No Code Available 64 64
Shaking/Tremors 63 63
Discomfort 62 62
Sweating 57 57
Blurred Vision 52 52
Swelling 52 52
Diarrhea 50 50
Rash 49 49
Skin Inflammation 49 49
Itching Sensation 48 48
Urinary Frequency 44 44
Weakness 43 43
No Information 40 40
Pneumonia 38 38
Renal Failure 37 37
Cardiac Arrest 37 37
Myocardial Infarction 36 36
Bone Fracture(s) 35 35
Reaction, Injection Site 33 33
Stroke/CVA 28 28
High Blood Pressure/ Hypertension 25 25
Urinary Tract Infection 25 25
Inflammation 22 22
Anxiety 22 22
Needle Stick/Puncture 21 21
Convulsion/Seizure 21 21
Fever 20 20
Hematoma 20 20
Erythema 19 19
Muscle Weakness 19 19
Scar Tissue 19 19
Lethargy 18 18
Fainting 17 17
Hemorrhage/Bleeding 16 16
Respiratory Distress 16 16
Irritation 15 15
Dysphagia/ Odynophagia 15 15
Overdose 14 14
Tachycardia 14 14
Scarring 13 13
Syncope 13 13
Cancer 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Shock, Insulin 12 12
Purulent Discharge 12 12
Visual Impairment 12 12
Hypersensitivity/Allergic reaction 11 11
Head Injury 10 10
Urinary Retention 10 10
Memory Loss/Impairment 10 10
Hyperemia 9 9
Congestive Heart Failure 9 9
Malaise 9 9
Injury 8 8
Foreign Body Reaction 8 8
Sepsis 8 8
Brain Injury 8 8
Bronchitis 7 7
Numbness 7 7
Dysuria 7 7
Pregnancy 6 6
Palpitations 6 6
Burn(s) 6 6
Pyrosis/Heartburn 6 6
Concussion 6 6
Cramp(s) 6 6
Neuropathy 6 6
Laceration(s) 5 5

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
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