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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 4
MEDTRONIC MINIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 32649 48058
2019 29027 36372
2020 32586 32693
2021 31526 31526
2022 28246 28246
2023 4280 4280

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 28407 36493
Unintended Movement 20749 24122
Insufficient Information 12548 17477
Loss of or Failure to Bond 11045 12224
Pumping Stopped 7512 7512
Activation, Positioning or Separation Problem 7378 17686
Mechanical Problem 6364 6364
Failure to Fire 6338 6338
Difficult to Insert 5997 5997
Fluid/Blood Leak 5404 5404
Premature Activation 4782 4782
Positioning Failure 4481 14774
Incorrect Measurement 4405 4421
Obstruction of Flow 4285 4285
Battery Problem 4259 4259
Charging Problem 3540 3540
Device Difficult to Program or Calibrate 3428 3428
Inadequate User Interface 3244 3244
Device Displays Incorrect Message 3228 4444
Adverse Event Without Identified Device or Use Problem 3189 3189
Retraction Problem 2895 13251
Inaccurate Delivery 2545 2711
Failure to Sense 2046 2115
False Alarm 1601 1601
Bent 1583 3776
Fail-Safe Did Not Operate 1510 1510
Device Sensing Problem 1291 1291
Failure to Cycle 1245 1245
Failure to Prime 1241 1396
Filling Problem 1155 1155
No Display/Image 1076 1961
Device Operates Differently Than Expected 942 942
Display Difficult to Read 925 925
Use of Device Problem 860 860
Break 853 853
Structural Problem 836 5741
Crack 815 815
Leak/Splash 795 8642
Detachment of Device or Device Component 746 746
Inappropriate or Unexpected Reset 691 691
Visual Prompts will not Clear 683 683
Physical Resistance/Sticking 651 651
Appropriate Term/Code Not Available 645 645
Premature Separation 625 625
Occlusion Within Device 566 566
Loose or Intermittent Connection 550 550
Image Display Error/Artifact 499 2988
Date/Time-Related Software Problem 475 593
Overheating of Device 471 471
Insufficient Flow or Under Infusion 466 466
Partial Blockage 456 489
Data Problem 433 433
Difficult or Delayed Activation 394 394
Fail-Safe Problem 389 1584
Device Alarm System 388 388
Power Problem 381 381
Poor Quality Image 372 372
Patient Device Interaction Problem 356 356
Premature Discharge of Battery 347 1172
Moisture Damage 324 1891
Electrical /Electronic Property Problem 300 1954
Display or Visual Feedback Problem 298 298
Fitting Problem 284 284
Failure To Adhere Or Bond 283 283
Pumping Problem 271 388
Material Split, Cut or Torn 268 268
Material Integrity Problem 254 254
Loss of Data 248 248
Computer Software Problem 243 243
Priming Problem 233 233
Device Inoperable 216 216
Failure to Read Input Signal 211 1179
Wireless Communication Problem 168 168
Failure to Power Up 163 163
No Apparent Adverse Event 161 161
Temperature Problem 159 307
Excess Flow or Over-Infusion 154 154
Communication or Transmission Problem 153 214
Intermittent Communication Failure 127 127
Device Issue 125 125
Material Deformation 123 123
Incorrect, Inadequate or Imprecise Result or Readings 113 113
Connection Problem 107 107
Physical Resistance 102 102
Thermal Decomposition of Device 85 85
Failure to Reset 81 81
Unable to Obtain Readings 69 69
Improper Flow or Infusion 64 64
Activation Problem 61 61
Material Separation 60 60
Moisture or Humidity Problem 59 59
Defective Alarm 58 234
Detachment Of Device Component 53 53
Reset Problem 47 47
Material Protrusion/Extrusion 46 46
Failure to Deliver 45 45
Component Falling 43 43
Scratched Material 38 38
Application Interface Becomes Non-Functional Or Program Exits Abnormally 32 32
Device Contamination with Chemical or Other Material 31 31

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hyperglycemia 73350 73350
No Consequences Or Impact To Patient 34428 46959
No Clinical Signs, Symptoms or Conditions 24622 24622
No Known Impact Or Consequence To Patient 8482 8482
No Information 8228 18521
Diabetic Ketoacidosis 4102 4102
Hypoglycemia 3208 3208
Insufficient Information 2416 2416
Vomiting 2162 2162
Pain 1825 1825
Skin Inflammation/ Irritation 1338 1338
Nausea 1256 1256
Unspecified Infection 1096 1096
Skin Infection 770 770
Skin Irritation 687 687
Purulent Discharge 639 639
Loss of consciousness 623 623
Dehydration 615 615
Irritation 553 553
Itching Sensation 356 356
Bruise/Contusion 311 311
Headache 301 301
Dizziness 265 265
Swelling/ Edema 263 263
Cellulitis 260 260
Abscess 256 256
Rash 236 236
No Patient Involvement 234 234
Swelling 161 161
Death 161 161
Chest Pain 151 151
Bacterial Infection 147 147
Hypersensitivity/Allergic reaction 134 134
Fever 125 125
Abdominal Pain 123 123
Urinary Frequency 115 115
Polydipsia 114 114
Coma 111 111
Scar Tissue 111 111
Seizures 110 110
Fatigue 110 110
Lethargy 93 93
Confusion/ Disorientation 92 92
Convulsion/Seizure 84 84
Diarrhea 83 83
Reaction 82 82
Burning Sensation 81 81
No Code Available 77 77
Blurred Vision 73 73
Abdominal Cramps 72 72
Cognitive Changes 66 66
Skin Inflammation 55 55
Renal Failure 46 46
Pneumonia 42 42
Weakness 41 41
Blood Loss 40 40
Urinary Tract Infection 38 38
Fall 38 38
Sweating 33 33
Ambulation Difficulties 33 33
Fainting 28 28
Burn(s) 28 28
Heart Failure 25 25
Hematoma 23 23
High Blood Pressure/ Hypertension 22 22
Cardiac Arrest 22 22
Chills 22 22
Contact Dermatitis 22 22
Anxiety 21 21
Numbness 20 20
Neuropathy 19 19
Virus 18 18
Myocardial Infarction 18 18
Sepsis 17 17
Skin Discoloration 17 17
Discomfort 17 17
Extreme Exhaustion 15 15
Dyspnea 15 15
Stroke/CVA 14 14
Respiratory Failure 13 13
Post Traumatic Wound Infection 12 12
Chemical Exposure 12 12
Cyst(s) 11 11
Caustic/Chemical Burns 10 10
Fluid Discharge 9 9
Hypoglycemic Shock 9 9
Cardiopulmonary Arrest 9 9
Hemorrhage/Bleeding 9 9
Inflammation 9 9
Bone Fracture(s) 8 8
Injury 8 8
Malaise 8 8
Depression 8 8
Staphylococcus Aureus 8 8
Visual Disturbances 8 8
Shaking/Tremors 8 8
Diaphoresis 7 7
Tachycardia 7 7
Septic Shock 7 7
Irritability 7 7

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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