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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
2019 29027 36372
2020 32586 32693
2021 31523 31523
2022 28229 28229
2023 22052 22052
2024 4639 4639

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 29195 34495
Unintended Movement 24360 24360
Loss of or Failure to Bond 16438 17617
Insufficient Information 12210 15959
Failure to Fire 8697 8697
Activation, Positioning or Separation Problem 7668 12997
Difficult to Insert 6753 6753
Mechanical Problem 6410 6410
Fluid/Blood Leak 6343 6343
Premature Activation 5674 5674
Battery Problem 4369 4369
Positioning Failure 4098 9412
Pumping Stopped 3855 3855
Obstruction of Flow 3344 3344
Retraction Problem 3288 8602
Device Difficult to Program or Calibrate 3091 3091
Inadequate User Interface 3023 3023
Incorrect Measurement 2716 2717
Inaccurate Delivery 2320 2341
Charging Problem 2106 2106
Adverse Event Without Identified Device or Use Problem 2000 2000
Failure to Sense 1657 1665
Fail-Safe Did Not Operate 1623 1623
Failure to Cycle 1412 1412
Display Difficult to Read 999 999
Break 992 992
Device Displays Incorrect Message 947 1194
No Display/Image 854 949
Device Sensing Problem 835 835
False Alarm 788 788
Premature Separation 709 709
Detachment of Device or Device Component 687 687
Overheating of Device 677 677
Appropriate Term/Code Not Available 665 665
Structural Problem 660 1552
Difficult or Delayed Activation 638 638
Physical Resistance/Sticking 571 571
Filling Problem 561 561
Inappropriate or Unexpected Reset 485 485
Power Problem 475 475
Image Display Error/Artifact 422 824
Material Integrity Problem 421 421
Crack 420 420
Loose or Intermittent Connection 392 392
Display or Visual Feedback Problem 385 385
Key or Button Unresponsive/not Working 363 363
Date/Time-Related Software Problem 354 357
Device Alarm System 342 342
Premature Discharge of Battery 323 400
Leak/Splash 318 3186
Loss of Data 314 314
Insufficient Flow or Under Infusion 313 313
Use of Device Problem 304 304
Priming Problem 300 300
Computer Software Problem 297 297
Poor Quality Image 289 289
Patient Device Interaction Problem 283 283
Data Problem 279 279
Visual Prompts will not Clear 260 260
Material Split, Cut or Torn 258 258
Moisture Damage 222 630
Electrical /Electronic Property Problem 212 537
Thermal Decomposition of Device 211 211
Fitting Problem 200 200
Excess Flow or Over-Infusion 179 179
Communication or Transmission Problem 169 178
Partial Blockage 164 169
Failure to Power Up 161 161
Failure to Prime 152 164
Intermittent Communication Failure 148 148
Wireless Communication Problem 134 134
No Apparent Adverse Event 134 134
Fail-Safe Problem 126 368
Failure to Read Input Signal 124 280
Connection Problem 114 114
Temperature Problem 91 104
Material Deformation 91 91
Incorrect, Inadequate or Imprecise Result or Readings 79 79
Moisture or Humidity Problem 69 69
Unable to Obtain Readings 67 67
Failure to Reset 66 66
Activation Problem 63 63
Failure of Device to Self-Test 56 56
Pumping Problem 55 70
Reset Problem 47 47
Improper Flow or Infusion 47 47
Unintended System Motion 46 46
Material Separation 39 39
Defective Alarm 36 69
Burst Container or Vessel 35 35
Environmental Compatibility Problem 32 32
Device Contamination with Chemical or Other Material 26 26
Device Emits Odor 25 25
Failure to Charge 24 24
Failure to Deliver 24 24
Device Damaged Prior to Use 24 24
Device Dislodged or Dislocated 24 24
Material Frayed 23 23
Application Program Problem: Dose Calculation Error 21 21
No Audible Alarm 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hyperglycemia 74382 74382
No Clinical Signs, Symptoms or Conditions 34395 34395
No Consequences Or Impact To Patient 17486 19624
No Information 8135 13449
No Known Impact Or Consequence To Patient 5715 5715
Diabetic Ketoacidosis 3406 3406
Hypoglycemia 2536 2536
Insufficient Information 2455 2455
Pain 2082 2082
Vomiting 2033 2033
Skin Inflammation/ Irritation 1746 1746
Nausea 1164 1164
Skin Infection 1028 1028
Unspecified Infection 820 820
Purulent Discharge 684 684
Loss of consciousness 667 667
Dehydration 530 530
Irritation 442 442
Skin Irritation 442 442
Itching Sensation 409 409
Swelling/ Edema 371 371
Bruise/Contusion 335 335
Headache 300 300
Abscess 275 275
Dizziness 261 261
Rash 253 253
Cellulitis 251 251
Hemorrhage/Bleeding 246 246
Hypersensitivity/Allergic reaction 147 147
Bacterial Infection 140 140
Scar Tissue 133 133
Fatigue 131 131
Chest Pain 129 129
Fever 121 121
Swelling 120 120
Convulsion/Seizure 115 115
Burning Sensation 109 109
Coma 108 108
Erythema 104 104
Death 103 103
Diarrhea 91 91
Abdominal Cramps 90 90
No Patient Involvement 88 88
Abdominal Pain 79 79
Reaction 65 65
Seizures 64 64
Cognitive Changes 64 64
Urinary Frequency 59 59
Blurred Vision 52 52
Urinary Tract Infection 45 45
Renal Failure 41 41
Pneumonia 39 39
Confusion/ Disorientation 39 39
Lethargy 39 39
No Code Available 39 39
Skin Inflammation 37 37
Fall 36 36
Blood Loss 35 35
Polydipsia 34 34
Burn(s) 32 32
Contact Dermatitis 31 31
Anxiety 30 30
Dyspnea 27 27
Weakness 26 26
Urticaria 25 25
Hematoma 25 25
Chills 23 23
Stroke/CVA 22 22
Numbness 21 21
Sweating 19 19
High Blood Pressure/ Hypertension 19 19
Myocardial Infarction 18 18
Neuropathy 18 18
Cardiac Arrest 18 18
Extreme Exhaustion 18 18
Discomfort 18 18
Heart Failure 18 18
Sepsis 17 17
Skin Discoloration 17 17
Inflammation 15 15
Eczema 15 15
Chemical Exposure 14 14
Respiratory Failure 14 14
Fluid Discharge 13 13
Hypoglycemic Shock 12 12
Virus 12 12
Fainting 11 11
Visual Disturbances 10 10
Caustic/Chemical Burns 10 10
Septic Shock 9 9
Cyst(s) 9 9
Cardiopulmonary Arrest 8 8
Abrasion 8 8
Peeling 8 8
Depression 8 8
Malaise 7 7
Needle Stick/Puncture 7 7
Ambulation Difficulties 7 7
Skin Tears 7 7
Fungal Infection 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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