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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device pump, infusion, insulin
Regulation Description Infusion pump.
Product CodeLZG
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
ASANTE SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
INSULET CORP.
  SUBSTANTIALLY EQUIVALENT 6
INSULET CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
TANDEM DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Pumping Stopped 18572
Cannula 17718
Device Displays Incorrect Message 14444
Adverse Event Without Identified Device or Use Problem 13767
Unintended Movement 10579
Device Operates Differently Than Expected 10509
Mechanical Problem 10097
Incorrect Measurement 9959
Occlusion Within Device 8488
Insufficient Information 7821
Tube 7310
Material Twisted / Bent 6913
Bent 5724
Charging Problem 5495
Failure to Prime 5100
Crack 4975
Filling Problem 4164
Structural Problem 3767
Poor Quality Image 3754
Needle 3669
No Display / Image 3592
False Alarm 3545
Inaccurate Delivery 3489
Break 3434
Battery Problem 3342
Display 3232
Use of Device Problem 2884
Image Display Error / Artifact 2610
Fail-Safe Problem 2603
Activation, Positioning or Separation Problem 2470
Obstruction of Flow 2377
Moisture Damage 2285
Visual Prompts will not Clear 2226
Failure to Sense 2037
Failure To Adhere Or Bond 1981
Leak / Splash 1971
Positioning Failure 1726
Difficult to Insert 1666
Loss of or Failure to Bond 1661
Partial Blockage 1636
Device Inoperable 1625
Kinked 1583
Switch, Push Button 1574
Housing 1374
Inappropriate or Unexpected Reset 1350
Device Difficult to Program or Calibrate 1350
Device Issue 1138
Fluid Leak 1132
Keypad 1110
Connection Problem 1080
Inadequate User Interface 1047
Electrical /Electronic Property Problem 1020
Battery 1011
Device Alarm System 1005
Date/Time-Related Software Problem 820
Pump 812
Device Sensing Problem 808
Insufficient Flow or Under Infusion 797
Data Problem 735
Premature Discharge of Battery 721
Loose or Intermittent Connection 635
Fitting Problem 606
Appropriate Term/Code Not Available 598
Failure to Read Input Signal 592
Screen 592
Difficult or Delayed Activation 544
Retraction Problem 534
Cover 506
Detachment Of Device Component 501
Physical Resistance 474
Moisture or Humidity Problem 452
Cap 434
Failure to Cycle 434
Fail-Safe Did Not Operate 433
Temperature Problem 414
Device Stops Intermittently 410
Detachment of Device or device Component 397
Loss of Power 388
Power Problem 359
Failure to Power Up 349
Physical Resistance / Sticking 277
Defective Alarm 277
Pumping Problem 268
Display Difficult to Read 264
Improper or Incorrect Procedure or Method 252
Material Discolored 248
Device Subassembly 241
Display or Visual Feedback Problem 233
Scratched Material 227
Infusion or Flow Problem 217
Patient Device Interaction Problem 217
Excess Flow or Over-Infusion 210
Out-Of-Box Failure 208
Disconnection 197
Wireless Communication Problem 196
Corroded 169
Unable to Obtain Readings 165
Communication or Transmission Problem 163
Material Deformation 134
Alarm 126
Total Device Problems 259625

Recalls
Manufacturer Recall Class Date Posted
1 Animas Corporation II Oct-24-2014
2 Elcam Medical, Inc. II Sep-10-2015
3 Insulet Corporation II Nov-07-2019
4 Insulet Corporation I Dec-15-2015
5 Insulet Corporation I Sep-04-2015
6 Medtronic Inc. I Nov-04-2019
7 Medtronic MiniMed III Jun-25-2015
8 Medtronic MiniMed Inc. III Mar-02-2015
9 Roche Diabetes Care, Inc. II Jun-09-2015
10 Roche Diagnostics Operations, Inc. II Oct-29-2014
11 Tandem Diabetes Care Inc I Feb-10-2014
12 Valeritas, Incorporated II Oct-26-2019

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