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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
ABBOTT DIABETES CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
ASANTE SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
ASANTE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSULET CORPORATION
  SUBSTANTIALLY EQUIVALENT 11
M2 GROUP HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDINGO LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC MINIMED
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC MINIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MODULAR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
TANDEM DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 7
VALERITAS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VALERITAS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 49177 49177
2015 69159 69159
2016 56614 64808
2017 44472 62462
2018 32651 48060
2019 29027 36372
2020 32586 32693
2021 31523 31523
2022 28229 28229
2023 22052 22052
2024 12692 12692

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 34453 38940
Material Twisted/Bent 32164 40250
Device Displays Incorrect Message 29324 32114
Pumping Stopped 20918 20918
Loss of or Failure to Bond 19299 20478
Insufficient Information 18580 23511
Crack 17973 17973
Device Operates Differently Than Expected 17473 18586
Mechanical Problem 16174 16202
Adverse Event Without Identified Device or Use Problem 15916 15916
Poor Quality Image 15170 17709
Break 13678 14464
Failure to Prime 12866 13574
No Display/Image 12473 14596
Incorrect Measurement 11692 11721
Battery Problem 11223 11431
Failure to Fire 9667 9667
Activation, Positioning or Separation Problem 9255 21550
Occlusion Within Device 9066 9113
Difficult to Insert 8036 8036
Fluid/Blood Leak 7660 7660
Inaccurate Delivery 7470 7860
Device Inoperable 7112 7722
Charging Problem 6883 6883
Premature Activation 5901 5901
Bent 5859 10039
Image Display Error/Artifact 5824 11835
Obstruction of Flow 5120 5120
Positioning Failure 5000 17280
Moisture Damage 4962 8557
Filling Problem 4522 4522
False Alarm 4013 4013
Structural Problem 3902 14865
Retraction Problem 3874 16297
Device Alarm System 3820 3837
Device Difficult to Program or Calibrate 3679 3679
Inadequate User Interface 3404 3404
Failure to Sense 3259 3442
Use of Device Problem 3187 3195
Fail-Safe Problem 2829 5156
Difficult or Delayed Activation 2816 2816
Leak/Splash 2728 10575
Visual Prompts will not Clear 2589 2589
Device Stops Intermittently 2235 2235
Moisture or Humidity Problem 2174 2372
Failure To Adhere Or Bond 1990 3977
Loss of Power 1957 1957
Inappropriate or Unexpected Reset 1940 1940
Fail-Safe Did Not Operate 1843 1843
Material Discolored 1793 1795

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hyperglycemia 138221 138270
No Known Impact Or Consequence To Patient 111454 119449
No Consequences Or Impact To Patient 93211 121877
No Clinical Signs, Symptoms or Conditions 38174 38174
Hypoglycemia 9735 9735
Diabetic Ketoacidosis 9433 9433
No Information 8944 21234
Vomiting 3870 3870
Nausea 3007 3007
Pain 2528 2528
Insufficient Information 2475 2475
Skin Inflammation/ Irritation 1861 1861
Unspecified Infection 1805 1805
Polydipsia 1607 1607
Dehydration 1395 1395
Skin Irritation 1362 1362
Loss of consciousness 1149 1149
Skin Infection 1110 1110
Urinary Frequency 1052 1052
No Patient Involvement 960 968
Dizziness 941 941
Purulent Discharge 866 866
Confusion/ Disorientation 750 750
Itching Sensation 660 660
Headache 659 659
Irritation 597 597
Abdominal Pain 582 582
Fatigue 458 458
Rash 454 454
Swelling/ Edema 425 425
Abscess 407 407
Blurred Vision 403 403
Bruise/Contusion 396 396
Hemorrhage/Bleeding 381 381
Cellulitis 366 366
Death 337 337
Lethargy 335 335
Chest Pain 325 325
Seizures 265 265
No Code Available 256 256
Cognitive Changes 247 247
Ambulation Difficulties 240 240
Coma 223 223
Swelling 192 192
Bacterial Infection 192 192
Dyspnea 192 192
Hypersensitivity/Allergic reaction 191 191
Erythema 174 174
Fever 172 172
Shaking/Tremors 163 163

Recalls
Manufacturer Recall Class Date Posted
1 Animas Corporation II Oct-24-2014
2 Animas Corporation I Apr-03-2013
3 Animas Corporation III Feb-17-2013
4 Animas Corporation II Oct-02-2012
5 Animas Corporation II Apr-06-2012
6 Animas Corporation II Aug-12-2011
7 Animas Corporation II May-10-2011
8 Animas Corporation II Sep-10-2010
9 Animas Corporation III May-08-2010
10 Animas Corporation II Mar-03-2009
11 Disetronic Medical Systems, Inc. II May-26-2009
12 Elcam Medical, Inc. II Sep-10-2015
13 Insulet Corporation I Nov-15-2022
14 Insulet Corporation II Mar-10-2021
15 Insulet Corporation II May-29-2020
16 Insulet Corporation II Mar-20-2020
17 Insulet Corporation II Nov-07-2019
18 Insulet Corporation I Dec-15-2015
19 Insulet Corporation I Sep-04-2015
20 Insulet Corporation II Nov-05-2013
21 Medtronic Inc. I Nov-04-2019
22 Medtronic MiniMed II Mar-26-2020
23 Medtronic MiniMed III Jun-25-2015
24 Medtronic MiniMed Inc. III Mar-02-2015
25 Roche Diabetes Care, Inc. II Aug-26-2021
26 Roche Diabetes Care, Inc. II Jun-09-2015
27 Roche Diagnostics Operations, Inc. II Oct-29-2014
28 Smiths Medical MD, Inc. II Apr-16-2009
29 Tandem Diabetes Care Inc I Feb-10-2014
30 Valeritas, Incorporated II Oct-26-2019
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