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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
INSULET CORP.
  SUBSTANTIALLY EQUIVALENT 5
INSULET CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
TANDEM DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Cannula 25382
Pumping Stopped 18240
Device Displays Incorrect Message 14581
Adverse Event Without Identified Device or Use Problem 13044
Unintended Movement 12346
Material Twisted/Bent 11209
Mechanical Problem 10680
Incorrect Measurement 10395
Device Operates Differently Than Expected 9832
Insufficient Information 9192
Needle 8334
Occlusion Within Device 7813
Tube 6150
Charging Problem 5971
Bent 5248
Failure to Prime 5080
Crack 4991
Activation, Positioning or SeparationProblem 4961
Filling Problem 4178
Battery Problem 4066
Positioning Failure 4002
Structural Problem 3856
Inaccurate Delivery 3826
Poor Quality Image 3743
No Display/Image 3644
Break 3540
False Alarm 3531
Display 3154
Obstruction of Flow 2976
Use of Device Problem 2789
Image Display Error/Artifact 2634
Fail-Safe Problem 2614
Loss of or Failure to Bond 2479
Difficult to Insert 2467
Failure to Sense 2331
Moisture Damage 2287
Visual Prompts will not Clear 2218
Failure To Adhere Or Bond 1970
Leak/Splash 1952
Device Difficult to Program or Calibrate 1760
Partial Blockage 1672
Fluid Leak 1588
Device Inoperable 1538
Switch, Push Button 1509
Inadequate User Interface 1462
Inappropriate or Unexpected Reset 1384
Housing 1365
Kinked 1317
Device Issue 1137
Device Sensing Problem 1057
Keypad 1055
Electrical /Electronic Property Problem 1054
Device Alarm System 1024
Battery 998
Retraction Problem 894
Date/Time-Related Software Problem 881
Insufficient Flow or Under Infusion 857
Pump 807
Data Problem 799
Premature Discharge of Battery 746
Loose or Intermittent Connection 729
Fitting Problem 644
Fail-Safe Did Not Operate 631
Adhesive 622
Failure to Read Input Signal 602
Appropriate Term/Code Not Available 596
Screen 570
Failure to Cycle 553
Difficult or Delayed Activation 539
Physical Resistance/Sticking 536
Cover 498
Detachment of Device or Device Component 482
Physical Resistance 473
Moisture or Humidity Problem 461
Detachment Of Device Component 459
Temperature Problem 427
Cap 424
Device Stops Intermittently 397
Loss of Power 380
Power Problem 376
Display Difficult to Read 373
Failure to Power Up 364
Patient Device Interaction Problem 284
Defective Alarm 278
Pumping Problem 271
Display or Visual Feedback Problem 264
Material Discolored 241
Device Subassembly 241
Scratched Material 226
Premature Separation 224
Improper or Incorrect Procedure or Method 221
Excess Flow or Over-Infusion 219
Infusion or Flow Problem 216
Out-Of-Box Failure 208
Premature Activation 185
Disconnection 185
Wireless Communication Problem 176
Corroded 168
Unable to Obtain Readings 164
Communication or Transmission Problem 161
Total Device Problems 287678

Recalls
Manufacturer Recall Class Date Posted
1 Elcam Medical, Inc. II Sep-10-2015
2 Insulet Corporation II May-29-2020
3 Insulet Corporation II Mar-20-2020
4 Insulet Corporation II Nov-07-2019
5 Insulet Corporation I Dec-15-2015
6 Insulet Corporation I Sep-04-2015
7 Medtronic Inc. II Mar-26-2020
8 Medtronic Inc. I Nov-04-2019
9 Medtronic MiniMed III Jun-25-2015
10 Medtronic MiniMed Inc. III Mar-02-2015
11 Roche Diabetes Care, Inc. II Jun-09-2015
12 Valeritas, Incorporated II Oct-26-2019

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