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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 5

MDR Year MDR Reports MDR Events
2016 21282 21282
2017 30435 30435
2018 39955 46985
2019 82390 83441
2020 77812 77812
2021 34266 34266

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 39986 41574
Adverse Event Without Identified Device or Use Problem 31798 31798
Patient Device Interaction Problem 31392 31392
Obstruction of Flow 20716 20716
Pumping Stopped 18639 18639
No Display/Image 17357 17357
Power Problem 13239 13239
Mechanical Problem 13187 19680
No Apparent Adverse Event 12849 12849
Device Difficult to Program or Calibrate 12754 13805
Break 12246 12246
Battery Problem 10357 10357
Incorrect Measurement 10301 10301
Charging Problem 8138 8138
Connection Problem 7340 7340
Incorrect, Inadequate or Imprecise Resultor Readings 6441 6441
Crack 6031 6031
Physical Resistance/Sticking 5818 5818
Device Operates Differently Than Expected 5529 7117
Failure to Sense 5507 5507
Device Alarm System 5228 5228
Filling Problem 5001 5001
Insufficient Information 4763 4763
Appropriate Term/Code Not Available 4265 4265
Display or Visual Feedback Problem 4249 4249
Moisture or Humidity Problem 3867 3867
Data Problem 3501 3501
False Alarm 3314 3314
Insufficient Flow or Under Infusion 3058 3058
Component Missing 3005 3005
Communication or Transmission Problem 2942 2942
Bent 2942 2942
Material Integrity Problem 2858 2858
Priming Problem 2751 2751
Use of Device Problem 2359 2359
Leak/Splash 2298 2298
Incorrect Or Inadequate Test Results 2221 2221
Device Inoperable 2212 2212
Detachment of Device or Device Component 2024 2024
Failure to Deliver 1993 1993
Failure to Cycle 1939 1939
Date/Time-Related Software Problem 1907 1907
Visual Prompts will not Clear 1889 1889
Device Sensing Problem 1801 1801
Circuit Failure 1635 1635
Unexpected Therapeutic Results 1587 1587
Partial Blockage 1580 1580
Excess Flow or Over-Infusion 1360 1360
Inappropriate or Unexpected Reset 1319 1319
Detachment Of Device Component 1257 1257
Premature Discharge of Battery 1214 1214
Moisture Damage 1204 1204
Poor Quality Image 1128 1128
Loss of Power 954 954
Calibration Problem 915 915
High Test Results 844 844
Loose or Intermittent Connection 809 809
Wireless Communication Problem 780 780
Component Falling 695 695
False Reading From Device Non-Compliance 693 693
Failure of Device to Self-Test 658 658
Noise, Audible 634 634
Computer Software Problem 629 629
Sticking 622 622
Fitting Problem 597 597
Improper or Incorrect Procedure or Method 590 590
Air Leak 584 584
Loss of Data 519 519
Scratched Material 518 518
Electrical /Electronic Property Problem 517 517
Calibration Error 511 511
Material Separation 500 500
Fracture 472 472
Fluid Leak 470 470
Material Protrusion/Extrusion 459 459
Failure to Power Up 427 427
Low Battery 413 413
Low Readings 411 411
Mechanical Jam 401 401
Material Twisted/Bent 341 341
Application Interface Becomes Non-Functional Or Program Exits Abnormally 303 303
Material Deformation 271 271
Temperature Problem 265 265
Inaccurate Delivery 261 261
Low Test Results 256 256
Loss of Threshold 256 256
Device Slipped 254 254
Improper Flow or Infusion 248 248
Failure to Prime 248 248
Difficult to Remove 244 244
Unintended Movement 237 237
Failure to Read Input Signal 235 235
Vibration 235 235
High Readings 232 232
Failure to Auto Stop 217 217
Device Markings/Labelling Problem 208 208
Invalid Sensing 207 207
Retraction Problem 205 205
Intermittent Communication Failure 195 195
Image Display Error/Artifact 190 190

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 140826 148907
Hyperglycemia 63328 63328
No Known Impact Or Consequence To Patient 34780 34780
Hypoglycemia 20502 20502
No Clinical Signs, Symptoms or Conditions 19832 19832
Insufficient Information 8846 8846
Diabetic Ketoacidosis 4867 4867
Nausea 1354 1354
Vomiting 1316 1316
Blood Loss 841 841
Death 683 683
Loss of consciousness 597 597
Abdominal Pain 421 421
Pain 349 349
Dyspnea 306 306
Headache 270 270
Polydipsia 229 229
Coma 227 227
Unspecified Infection 225 225
Seizures 225 225
No Patient Involvement 187 187
Complaint, Ill-Defined 186 186
Foreign Body In Patient 182 182
Skin Irritation 181 181
Fatigue 174 174
Dizziness 171 171
Dehydration 163 163
Bruise/Contusion 125 125
Confusion/ Disorientation 116 116
No Information 114 114
No Code Available 109 109
Fall 109 109
Sweating 105 105
Urinary Frequency 102 102
Chest Pain 96 96
Hemorrhage/Bleeding 83 83
Shaking/Tremors 72 72
Discomfort 68 68
Swelling 68 68
Weakness 68 68
Blurred Vision 59 59
Diarrhea 58 58
Overdose 57 57
Itching Sensation 56 56
Myocardial Infarction 50 50
Pneumonia 50 50
Renal Failure 50 50
Skin Inflammation 50 50
Malaise 50 50
Rash 48 48
Respiratory Distress 45 45
Cardiac Arrest 40 40
Lethargy 40 40
Bone Fracture(s) 37 37
High Blood Pressure/ Hypertension 36 36
Stroke/CVA 36 36
Urinary Tract Infection 34 34
Fever 33 33
Reaction, Injection Site 33 33
Scar Tissue 32 32
Tachycardia 32 32
Erythema 27 27
Syncope 27 27
Irritation 26 26
Fainting 25 25
Inflammation 23 23
Anxiety 22 22
Needle Stick/Puncture 21 21
Hematoma 21 21
Congestive Heart Failure 20 20
Cancer 17 17
Cramp(s) 16 16
Dysphagia/ Odynophagia 16 16
Purulent Discharge 16 16
Convulsion/Seizure 15 15
Device Embedded In Tissue or Plaque 15 15
Shock, Insulin 14 14
Scarring 14 14
Visual Impairment 13 13
Injury 13 13
Palpitations 13 13
Underdose 13 13
Brain Injury 12 12
Head Injury 12 12
Hypersensitivity/Allergic reaction 12 12
Hyperemia 10 10
Numbness 10 10
Urinary Retention 9 9
Tingling 9 9
Ambulation Difficulties 9 9
Cognitive Changes 9 9
Pregnancy 8 8
Unspecified Tissue Injury 8 8
Virus 8 8
Sore Throat 8 8
Low Blood Pressure/ Hypotension 8 8
Memory Loss/Impairment 8 8
Laceration(s) 8 8
Neuropathy 8 8
Foreign Body Reaction 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 Inc. II Dec-22-2018
5 Medtronic Inc. II Feb-21-2018
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