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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)
2016 2017 2018 2019 2020 2021
28 29 53 31 8 3

MDR Year MDR Reports MDR Events
2016 21282 21282
2017 30439 30439
2018 39955 46985
2019 82391 83442
2020 77826 77826
2021 13605 13605

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 39988 41576
Patient Device Interaction Problem 31353 31353
Adverse Event Without Identified Device or Use Problem 30032 30032
Obstruction of Flow 19411 19411
No Display/Image 16283 16283
Pumping Stopped 16152 16152
No Apparent Adverse Event 12439 12439
Mechanical Problem 12058 18551
Device Difficult to Program or Calibrate 11911 12962
Power Problem 11683 11683
Battery Problem 9530 9530
Incorrect Measurement 9431 9431
Break 7412 7412
Charging Problem 6708 6708
Connection Problem 6480 6480
Incorrect, Inadequate or Imprecise Resultor Readings 6339 6339
Physical Resistance/Sticking 5553 5553
Device Operates Differently Than Expected 5529 7117
Crack 5315 5315
Device Alarm System 4912 4912
Insufficient Information 4727 4727
Failure to Sense 4648 4648
Filling Problem 4610 4610
Appropriate Term/Code Not Available 4136 4136
Display or Visual Feedback Problem 4007 4007
Moisture or Humidity Problem 3279 3279
Data Problem 3213 3213
Component Missing 3003 3003
Bent 2942 2942
Insufficient Flow or Under Infusion 2877 2877
False Alarm 2780 2780
Material Integrity Problem 2643 2643
Priming Problem 2635 2635
Use of Device Problem 2347 2347
Incorrect Or Inadequate Test Results 2221 2221
Device Inoperable 2212 2212
Leak/Splash 2184 2184
Communication or Transmission Problem 2000 2000
Failure to Deliver 1991 1991
Detachment of Device or Device Component 1902 1902
Failure to Cycle 1855 1855
Visual Prompts will not Clear 1789 1789
Date/Time-Related Software Problem 1678 1678
Device Sensing Problem 1654 1654
Partial Blockage 1490 1490
Unexpected Therapeutic Results 1488 1488
Circuit Failure 1476 1476
Detachment Of Device Component 1258 1258
Excess Flow or Over-Infusion 1256 1256
Moisture Damage 1203 1203
Inappropriate or Unexpected Reset 1196 1196
Premature Discharge of Battery 1169 1169
Loss of Power 954 954
Poor Quality Image 890 890
Calibration Problem 884 884
High Test Results 844 844
Wireless Communication Problem 767 767
Loose or Intermittent Connection 737 737
Component Falling 695 695
False Reading From Device Non-Compliance 693 693
Noise, Audible 634 634
Sticking 622 622
Failure of Device to Self-Test 595 595
Improper or Incorrect Procedure or Method 590 590
Air Leak 584 584
Computer Software Problem 574 574
Fitting Problem 548 548
Scratched Material 518 518
Calibration Error 511 511
Material Separation 496 496
Electrical /Electronic Property Problem 472 472
Fluid Leak 470 470
Loss of Data 460 460
Material Protrusion/Extrusion 459 459
Fracture 455 455
Failure to Power Up 424 424
Low Battery 413 413
Low Readings 411 411
Mechanical Jam 351 351
Material Twisted/Bent 325 325
Application Interface Becomes Non-Functional Or Program Exits Abnormally 303 303
Material Deformation 271 271
Inaccurate Delivery 260 260
Low Test Results 256 256
Loss of Threshold 256 256
Device Slipped 254 254
Failure to Prime 248 248
Difficult to Remove 243 243
Temperature Problem 238 238
Failure to Read Input Signal 235 235
Vibration 235 235
Improper Flow or Infusion 233 233
High Readings 232 232
Unintended Movement 208 208
Invalid Sensing 207 207
Retraction Problem 205 205
Failure to Auto Stop 199 199
Image Display Error/Artifact 190 190
Occlusion Within Device 188 188
Intermittent Communication Failure 188 188

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 140832 148913
Hyperglycemia 61245 61245
No Known Impact Or Consequence To Patient 34783 34783
Hypoglycemia 19639 19639
No Clinical Signs, Symptoms or Conditions 7834 7834
Diabetic Ketoacidosis 4638 4638
Insufficient Information 3103 3103
Nausea 1297 1297
Vomiting 1262 1262
Blood Loss 841 841
Death 683 683
Loss of consciousness 572 572
Abdominal Pain 402 402
Pain 338 338
Dyspnea 299 299
Headache 245 245
Seizures 225 225
Unspecified Infection 222 222
Coma 217 217
Polydipsia 214 214
No Patient Involvement 187 187
Complaint, Ill-Defined 186 186
Skin Irritation 181 181
Foreign Body In Patient 179 179
Dehydration 160 160
Dizziness 156 156
Fatigue 147 147
Bruise/Contusion 121 121
No Information 114 114
No Code Available 109 109
Sweating 105 105
Fall 104 104
Urinary Frequency 101 101
Confusion/ Disorientation 92 92
Chest Pain 91 91
Hemorrhage/Bleeding 82 82
Weakness 68 68
Discomfort 68 68
Swelling 68 68
Shaking/Tremors 66 66
Overdose 57 57
Itching Sensation 56 56
Diarrhea 55 55
Blurred Vision 51 51
Malaise 50 50
Skin Inflammation 50 50
Renal Failure 47 47
Rash 47 47
Myocardial Infarction 46 46
Pneumonia 46 46
Respiratory Distress 45 45
Lethargy 39 39
Cardiac Arrest 36 36
Stroke/CVA 34 34
High Blood Pressure/ Hypertension 34 34
Reaction, Injection Site 33 33
Urinary Tract Infection 33 33
Bone Fracture(s) 32 32
Fever 32 32
Tachycardia 31 31
Scar Tissue 30 30
Syncope 27 27
Irritation 26 26
Erythema 25 25
Fainting 25 25
Inflammation 22 22
Hematoma 20 20
Congestive Heart Failure 20 20
Anxiety 19 19
Needle Stick/Puncture 18 18
Purulent Discharge 16 16
Dysphagia/ Odynophagia 16 16
Cramp(s) 16 16
Cancer 16 16
Scarring 14 14
Shock, Insulin 14 14
Device Embedded In Tissue or Plaque 14 14
Injury 13 13
Underdose 13 13
Palpitations 13 13
Hypersensitivity/Allergic reaction 12 12
Brain Injury 12 12
Visual Impairment 12 12
Head Injury 12 12
Numbness 10 10
Ambulation Difficulties 9 9
Tingling 9 9
Virus 8 8
Sore Throat 8 8
Foreign Body Reaction 8 8
Bronchitis 8 8
Hyperemia 8 8
Cognitive Changes 8 8
Pregnancy 8 8
Low Blood Pressure/ Hypotension 8 8
Memory Loss/Impairment 8 8
Neuropathy 8 8
Pyrosis/Heartburn 7 7
Burn(s) 7 7
Laceration(s) 7 7

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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