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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 0

MDR Year MDR Reports MDR Events
2017 30435 30435
2018 39955 46985
2019 82390 83441
2020 77812 77812
2021 41447 41447

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 34058 35646
Patient Device Interaction Problem 31396 31396
Adverse Event Without Identified Device or Use Problem 29935 29935
Obstruction of Flow 21074 21074
Pumping Stopped 19560 19560
No Display/Image 15838 15838
Power Problem 13449 13449
Mechanical Problem 13419 19912
Break 13360 13360
No Apparent Adverse Event 12987 12987
Device Difficult to Program or Calibrate 12919 13970
Incorrect Measurement 10631 10631
Battery Problem 10324 10324
Charging Problem 8659 8659
Connection Problem 7626 7626
Physical Resistance/Sticking 5937 5937
Failure to Sense 5765 5765
Crack 5610 5610
Incorrect, Inadequate or Imprecise Resultor Readings 5397 5397
Filling Problem 5120 5120
Device Alarm System 4926 4926
Appropriate Term/Code Not Available 4426 4426
Display or Visual Feedback Problem 4257 4257
Device Operates Differently Than Expected 3624 5212
Moisture or Humidity Problem 3623 3623
Data Problem 3574 3574
False Alarm 3448 3448
Insufficient Information 3283 3283
Insufficient Flow or Under Infusion 3102 3102
Communication or Transmission Problem 2998 2998
Material Integrity Problem 2905 2905
Priming Problem 2772 2772
Use of Device Problem 2314 2314
Leak/Splash 2255 2255
Detachment of Device or Device Component 2031 2031
Date/Time-Related Software Problem 1985 1985
Failure to Cycle 1952 1952
Component Missing 1915 1915
Visual Prompts will not Clear 1835 1835
Device Sensing Problem 1778 1778
Circuit Failure 1657 1657
Bent 1637 1637
Unexpected Therapeutic Results 1612 1612
Partial Blockage 1600 1600
Incorrect Or Inadequate Test Results 1596 1596
Device Inoperable 1374 1374
Inappropriate or Unexpected Reset 1341 1341
Excess Flow or Over-Infusion 1311 1311
Failure to Deliver 1280 1280
Premature Discharge of Battery 1166 1166
Poor Quality Image 1148 1148
Detachment Of Device Component 982 982
Calibration Problem 833 833
Wireless Communication Problem 783 783
Loose or Intermittent Connection 753 753
Moisture Damage 749 749
Loss of Power 691 691
Computer Software Problem 633 633
High Test Results 631 631
Fitting Problem 599 599
Failure of Device to Self-Test 596 596
Loss of Data 518 518
Electrical /Electronic Property Problem 517 517
Material Separation 484 484
Component Falling 463 463
False Reading From Device Non-Compliance 462 462
Fracture 454 454
Noise, Audible 429 429
Mechanical Jam 389 389
Sticking 382 382
Material Protrusion/Extrusion 376 376
Material Twisted/Bent 345 345
Air Leak 345 345
Low Battery 342 342
Failure to Power Up 340 340
Fluid Leak 333 333
Scratched Material 333 333
Calibration Error 315 315
Temperature Problem 271 271
Low Readings 267 267
Improper or Incorrect Procedure or Method 263 263
Unintended Movement 244 244
Application Interface Becomes Non-Functional Or Program Exits Abnormally 235 235
Failure to Auto Stop 223 223
Improper Flow or Infusion 217 217
Device Markings/Labelling Problem 214 214
Failure to Read Input Signal 213 213
High Readings 204 204
Device Slipped 199 199
Invalid Sensing 197 197
Intermittent Communication Failure 197 197
Material Deformation 189 189
Inaccurate Delivery 180 180
Overheating of Device 176 176
Human-Device Interface Problem 174 174
Low Test Results 168 168
Difficult to Remove 164 164
Failure to Prime 162 162
Vibration 159 159
Occlusion Within Device 155 155

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 140821 148902
Hyperglycemia 51384 51384
No Known Impact Or Consequence To Patient 29069 29069
No Clinical Signs, Symptoms or Conditions 24382 24382
Hypoglycemia 17174 17174
Insufficient Information 10391 10391
Diabetic Ketoacidosis 4009 4009
Nausea 1030 1030
Vomiting 974 974
Blood Loss 829 829
Death 578 578
Loss of consciousness 475 475
Abdominal Pain 347 347
Dyspnea 262 262
Pain 262 262
Coma 200 200
No Patient Involvement 182 182
Foreign Body In Patient 177 177
Headache 174 174
Seizures 168 168
Skin Irritation 160 160
Complaint, Ill-Defined 135 135
Unspecified Infection 134 134
Fatigue 121 121
Bruise/Contusion 119 119
Polydipsia 117 117
Dizziness 110 110
Dehydration 102 102
Confusion/ Disorientation 88 88
Fall 69 69
Chest Pain 68 68
No Code Available 64 64
Discomfort 62 62
Unspecified Tissue Injury 58 58
Sweating 57 57
Swelling 52 52
Shaking/Tremors 50 50
Skin Inflammation 49 49
Itching Sensation 48 48
Rash 47 47
Diarrhea 46 46
Weakness 43 43
Urinary Frequency 43 43
Blurred Vision 42 42
No Information 40 40
Pneumonia 36 36
Myocardial Infarction 34 34
Renal Failure 33 33
Bone Fracture(s) 33 33
Reaction, Injection Site 33 33
Cardiac Arrest 30 30
Stroke/CVA 26 26
High Blood Pressure/ Hypertension 24 24
Urinary Tract Infection 24 24
Inflammation 22 22
Needle Stick/Puncture 21 21
Fever 20 20
Erythema 19 19
Hematoma 19 19
Scar Tissue 19 19
Anxiety 19 19
Lethargy 17 17
Convulsion/Seizure 17 17
Fainting 17 17
Hemorrhage/Bleeding 16 16
Respiratory Distress 16 16
Irritation 15 15
Dysphagia/ Odynophagia 15 15
Overdose 14 14
Scarring 13 13
Tachycardia 13 13
Syncope 13 13
Purulent Discharge 12 12
Shock, Insulin 12 12
Visual Impairment 11 11
Hypersensitivity/Allergic reaction 10 10
Cancer 10 10
Malaise 9 9
Hyperemia 9 9
Congestive Heart Failure 9 9
Urinary Retention 9 9
Memory Loss/Impairment 9 9
Foreign Body Reaction 8 8
Head Injury 8 8
Injury 8 8
Dysuria 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Bronchitis 7 7
Sepsis 7 7
Brain Injury 7 7
Concussion 6 6
Cramp(s) 6 6
Burn(s) 6 6
Pregnancy 6 6
Palpitations 6 6
Numbness 6 6
Sore Throat 5 5
Respiratory Tract Infection 5 5
Low Blood Pressure/ Hypotension 5 5
Hypothermia 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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