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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, infusion, insulin
Product CodeLZG
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
INSULET CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC MINIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 32651 48060
2019 29027 36372
2020 32586 32693
2021 31523 31523
2022 28229 28229
2023 20559 20559

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 30679 38765
Unintended Movement 25775 29148
Loss of or Failure to Bond 15455 16634
Insufficient Information 13663 18592
Activation, Positioning or Separation Problem 7882 18190
Failure to Fire 7818 7818
Pumping Stopped 7585 7585
Mechanical Problem 7341 7341
Difficult to Insert 6803 6803
Fluid/Blood Leak 6397 6397
Premature Activation 5457 5457
Battery Problem 4763 4763
Obstruction of Flow 4508 4508
Positioning Failure 4481 14774
Incorrect Measurement 4473 4489
Device Difficult to Program or Calibrate 3657 3657
Charging Problem 3574 3574
Inadequate User Interface 3395 3395
Adverse Event Without Identified Device or Use Problem 3284 3284
Device Displays Incorrect Message 3228 4444
Retraction Problem 3211 13567
Inaccurate Delivery 2771 2937
Failure to Sense 2140 2209
Fail-Safe Did Not Operate 1705 1705
False Alarm 1606 1606
Bent 1583 3776
Failure to Cycle 1511 1511
Device Sensing Problem 1338 1338
Failure to Prime 1241 1396
No Display/Image 1196 2081
Filling Problem 1158 1158
Display Difficult to Read 1046 1046
Break 946 946
Device Operates Differently Than Expected 943 943
Use of Device Problem 889 889
Structural Problem 836 5741
Crack 826 826
Detachment of Device or Device Component 824 824
Leak/Splash 798 8645
Inappropriate or Unexpected Reset 758 758
Appropriate Term/Code Not Available 713 713
Visual Prompts will not Clear 703 703
Premature Separation 695 695
Overheating of Device 674 674
Physical Resistance/Sticking 651 651
Occlusion Within Device 566 566
Loose or Intermittent Connection 565 565
Difficult or Delayed Activation 543 543
Image Display Error/Artifact 499 2988
Date/Time-Related Software Problem 498 616
Insufficient Flow or Under Infusion 475 475
Power Problem 467 467
Partial Blockage 456 489
Data Problem 434 434
Device Alarm System 418 418
Display or Visual Feedback Problem 396 396
Fail-Safe Problem 389 1584
Poor Quality Image 382 382
Material Integrity Problem 374 374
Premature Discharge of Battery 372 1197
Patient Device Interaction Problem 358 358
Moisture Damage 324 1891
Loss of Data 320 320
Computer Software Problem 304 304
Electrical /Electronic Property Problem 302 1956
Priming Problem 295 295
Fitting Problem 291 291
Material Split, Cut or Torn 288 288
Failure To Adhere Or Bond 283 283
Pumping Problem 271 388
Device Inoperable 216 216
Failure to Read Input Signal 211 1179
Thermal Decomposition of Device 201 201
Failure to Power Up 195 195
Wireless Communication Problem 190 190
Communication or Transmission Problem 179 240
Excess Flow or Over-Infusion 172 172
Temperature Problem 162 310
No Apparent Adverse Event 161 161
Intermittent Communication Failure 149 149
Device Issue 125 125
Material Deformation 124 124
Connection Problem 123 123
Incorrect, Inadequate or Imprecise Result or Readings 116 116
Physical Resistance 102 102
Failure to Reset 81 81
Unable to Obtain Readings 69 69
Moisture or Humidity Problem 69 69
Improper Flow or Infusion 65 65
Activation Problem 64 64
Material Separation 61 61
Defective Alarm 59 235
Reset Problem 57 57
Detachment Of Device Component 53 53
Failure to Deliver 47 47
Material Protrusion/Extrusion 46 46
Component Falling 43 43
Scratched Material 38 38
Failure of Device to Self-Test 37 37
Key or Button Unresponsive/not Working 36 36

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hyperglycemia 82382 82382
No Consequences Or Impact To Patient 34428 46959
No Clinical Signs, Symptoms or Conditions 31187 31187
No Known Impact Or Consequence To Patient 8482 8482
No Information 8228 18521
Diabetic Ketoacidosis 4398 4398
Hypoglycemia 3434 3434
Insufficient Information 2452 2452
Vomiting 2339 2339
Pain 2122 2122
Skin Inflammation/ Irritation 1624 1624
Nausea 1366 1366
Unspecified Infection 1101 1101
Skin Infection 954 954
Purulent Discharge 726 726
Loss of consciousness 720 720
Skin Irritation 687 687
Dehydration 660 660
Irritation 553 553
Itching Sensation 422 422
Bruise/Contusion 351 351
Headache 337 337
Swelling/ Edema 330 330
Dizziness 301 301
Abscess 294 294
Cellulitis 280 280
Rash 271 271
No Patient Involvement 234 234
Chest Pain 163 163
Hemorrhage/Bleeding 162 162
Death 161 161
Swelling 161 161
Bacterial Infection 157 157
Hypersensitivity/Allergic reaction 143 143
Fever 142 142
Scar Tissue 130 130
Fatigue 128 128
Coma 125 125
Abdominal Pain 124 124
Polydipsia 124 124
Urinary Frequency 119 119
Seizures 110 110
Convulsion/Seizure 106 106
Burning Sensation 103 103
Lethargy 96 96
Confusion/ Disorientation 95 95
Diarrhea 92 92
Abdominal Cramps 91 91
Reaction 82 82
Blurred Vision 79 79
No Code Available 77 77
Cognitive Changes 76 76
Skin Inflammation 55 55
Erythema 54 54
Renal Failure 48 48
Urinary Tract Infection 45 45
Pneumonia 43 43
Fall 42 42
Weakness 41 41
Blood Loss 40 40
Ambulation Difficulties 34 34
Sweating 33 33
Burn(s) 33 33
Dyspnea 30 30
Fainting 28 28
Anxiety 28 28
Contact Dermatitis 27 27
Chills 26 26
Numbness 26 26
Heart Failure 25 25
Cardiac Arrest 24 24
Hematoma 23 23
Myocardial Infarction 23 23
High Blood Pressure/ Hypertension 22 22
Neuropathy 20 20
Discomfort 20 20
Urticaria 19 19
Virus 18 18
Stroke/CVA 18 18
Extreme Exhaustion 18 18
Sepsis 17 17
Skin Discoloration 17 17
Inflammation 16 16
Respiratory Failure 14 14
Chemical Exposure 13 13
Fluid Discharge 12 12
Shaking/Tremors 12 12
Post Traumatic Wound Infection 12 12
Hypoglycemic Shock 12 12
Eczema 11 11
Cyst(s) 11 11
Visual Disturbances 11 11
Malaise 10 10
Bone Fracture(s) 10 10
Caustic/Chemical Burns 10 10
Low Blood Pressure/ Hypotension 9 9
Cardiopulmonary Arrest 9 9
Dysphasia 9 9
Septic Shock 9 9
Staphylococcus Aureus 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Insulet Corporation I Nov-15-2022
2 Insulet Corporation II Mar-10-2021
3 Insulet Corporation II May-29-2020
4 Insulet Corporation II Mar-20-2020
5 Insulet Corporation II Nov-07-2019
6 Medtronic Inc. I Nov-04-2019
7 Medtronic MiniMed II Mar-26-2020
8 Roche Diabetes Care, Inc. II Aug-26-2021
9 Valeritas, Incorporated II Oct-26-2019
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