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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 6129 6129

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 29350 34650
Unintended Movement 24739 24739
Loss of or Failure to Bond 16783 17962
Insufficient Information 12294 16043
Failure to Fire 8911 8911
Activation, Positioning or Separation Problem 7686 13015
Difficult to Insert 6808 6808
Mechanical Problem 6515 6515
Fluid/Blood Leak 6429 6429
Premature Activation 5732 5732
Battery Problem 4392 4392
Positioning Failure 4098 9412
Pumping Stopped 3860 3860
Obstruction of Flow 3437 3437
Retraction Problem 3304 8618
Device Difficult to Program or Calibrate 3091 3091
Inadequate User Interface 3023 3023
Incorrect Measurement 2718 2719
Inaccurate Delivery 2346 2367
Charging Problem 2109 2109
Adverse Event Without Identified Device or Use Problem 2010 2010
Failure to Sense 1660 1668
Fail-Safe Did Not Operate 1641 1641
Failure to Cycle 1429 1429
Break 1032 1032
Display Difficult to Read 1009 1009
Device Displays Incorrect Message 947 1194
No Display/Image 868 963
Device Sensing Problem 836 836
False Alarm 788 788
Premature Separation 709 709
Detachment of Device or Device Component 695 695
Overheating of Device 680 680
Appropriate Term/Code Not Available 677 677
Difficult or Delayed Activation 662 662
Structural Problem 660 1552
Physical Resistance/Sticking 571 571
Filling Problem 561 561
Inappropriate or Unexpected Reset 490 490
Power Problem 486 486
Material Integrity Problem 435 435
Image Display Error/Artifact 422 824
Crack 420 420
Key or Button Unresponsive/not Working 414 414
Display or Visual Feedback Problem 394 394
Loose or Intermittent Connection 393 393
Date/Time-Related Software Problem 355 358
Device Alarm System 346 346
Priming Problem 326 326
Premature Discharge of Battery 325 402
Loss of Data 324 324
Leak/Splash 318 3186
Insufficient Flow or Under Infusion 314 314
Use of Device Problem 311 311
Computer Software Problem 307 307
Poor Quality Image 289 289
Patient Device Interaction Problem 283 283
Data Problem 279 279
Visual Prompts will not Clear 268 268
Material Split, Cut or Torn 262 262
Moisture Damage 222 630
Thermal Decomposition of Device 216 216
Electrical /Electronic Property Problem 212 537
Fitting Problem 200 200
Excess Flow or Over-Infusion 181 181
Communication or Transmission Problem 172 181
Partial Blockage 164 169
Failure to Power Up 162 162
Failure to Prime 152 164
Intermittent Communication Failure 149 149
No Apparent Adverse Event 135 135
Wireless Communication Problem 134 134
Fail-Safe Problem 126 368
Failure to Read Input Signal 124 280
Connection Problem 114 114
Material Deformation 91 91
Temperature Problem 91 104
Incorrect, Inadequate or Imprecise Result or Readings 80 80
Moisture or Humidity Problem 71 71
Unable to Obtain Readings 67 67
Failure to Reset 66 66
Activation Problem 63 63
Failure of Device to Self-Test 61 61
Pumping Problem 55 70
Reset Problem 47 47
Improper Flow or Infusion 47 47
Unintended System Motion 47 47
Material Separation 39 39
Burst Container or Vessel 37 37
Defective Alarm 36 69
Environmental Compatibility Problem 34 34
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 75075 75075
No Clinical Signs, Symptoms or Conditions 35143 35143
No Consequences Or Impact To Patient 17486 19624
No Information 8135 13449
No Known Impact Or Consequence To Patient 5715 5715
Diabetic Ketoacidosis 3421 3421
Hypoglycemia 2553 2553
Insufficient Information 2455 2455
Pain 2114 2114
Vomiting 2044 2044
Skin Inflammation/ Irritation 1769 1769
Nausea 1177 1177
Skin Infection 1039 1039
Unspecified Infection 825 825
Purulent Discharge 695 695
Loss of consciousness 674 674
Dehydration 533 533
Irritation 442 442
Skin Irritation 442 442
Itching Sensation 413 413
Swelling/ Edema 387 387
Bruise/Contusion 339 339
Headache 302 302
Abscess 277 277
Hemorrhage/Bleeding 266 266
Dizziness 265 265
Rash 254 254
Cellulitis 253 253
Hypersensitivity/Allergic reaction 150 150
Bacterial Infection 140 140
Fatigue 135 135
Scar Tissue 134 134
Chest Pain 129 129
Fever 123 123
Swelling 120 120
Convulsion/Seizure 117 117
Burning Sensation 114 114
Erythema 112 112
Coma 111 111
Death 103 103
Diarrhea 93 93
Abdominal Cramps 92 92
No Patient Involvement 88 88
Abdominal Pain 79 79
Reaction 65 65
Seizures 64 64
Cognitive Changes 64 64
Urinary Frequency 62 62
Blurred Vision 52 52
Urinary Tract Infection 45 45
Renal Failure 41 41
Lethargy 40 40
Confusion/ Disorientation 39 39
No Code Available 39 39
Pneumonia 39 39
Skin Inflammation 37 37
Fall 36 36
Blood Loss 35 35
Polydipsia 34 34
Contact Dermatitis 34 34
Burn(s) 32 32
Anxiety 30 30
Urticaria 29 29
Dyspnea 27 27
Weakness 26 26
Hematoma 25 25
Chills 23 23
Stroke/CVA 22 22
Discomfort 21 21
Numbness 21 21
Sweating 19 19
High Blood Pressure/ Hypertension 19 19
Neuropathy 19 19
Myocardial Infarction 18 18
Cardiac Arrest 18 18
Extreme Exhaustion 18 18
Heart Failure 18 18
Sepsis 17 17
Skin Discoloration 17 17
Eczema 17 17
Inflammation 15 15
Respiratory Failure 14 14
Chemical Exposure 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
Malaise 8 8
Depression 8 8
Ambulation Difficulties 7 7
Skin Tears 7 7
Needle Stick/Puncture 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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