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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, to be used with invasive glucose sensor
Definition The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.
Product CodeOYC
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 1 1 17 2

Device Problems
Device displays error message 19854
Device operates differently than expected 4433
Structural problem 3368
Device inoperable 2972
Pumping stopped 2806
No Known Device Problem 2414
Wireless communication issue 2010
No display or display failure 1720
Incorrect measurement 1540
Image display error 1480
Crack 1191
Mechanical issue 997
Moisture damage 970
Occlusion within device 967
Charging issue 910
Fail-safe mechanism issue 847
Battery issue 770
Use of Device Issue 719
Break 714
Failure to deliver 508
Filling problem 481
Prompts will not clear 473
Moisture or humidity problem 473
Failure to prime 471
Invalid sensing 467
Electrical issue 460
Self-activation or keying 442
Device alarm system issue 398
Sticking 396
Failure to read input signal 382
Improper or incorrect procedure or method 381
Blockage within device or device component 372
Material Protrusion 331
Application interface becomes non-functional or program exits abnormally 256
Loss of power 249
Scratched material 247
Premature discharge of battery 242
Loose or intermittent connection 235
Component falling 225
Detachment of device component 220
Fluid leak 212
Component missing 206
Failure to sense 205
Retraction problem 193
Reset issue 192
Improper flow or infusion 182
Leak 176
No Information 159
Device stops intermittently 155
Inaccurate delivery 153
Inappropriate or unexpected reset 151
Noise, Audible 151
False alarm 139
Device Issue 138
Failure to power-up 131
Poor quality image 113
Electro-magnetic interference (EMI) 104
Difficult or delayed activation 101
Date-related software issue 101
Low battery 86
Temperature issue 82
Failure of device to self-test 82
Defective Alarm 74
Physical resistance 72
Excess flow or overinfusion 69
Erratic display 68
Fitting problem 68
Bent 67
Device sensing issue 67
Vibration 64
Malposition of device 63
Data Issue 61
Insufficient flow or underinfusion 59
Slippage of device or device component 59
Unintended collision 59
Out-of-box failure 58
Detachment of device or device component 53
Communication or transmission issue 51
Air leak 51
Infusion or flow issue 50
Power source issue 48
Unable to obtain readings 48
Material discolored 47
Corrosion 46
High test results 44
Disconnection 37
Not audible alarm 36
Dislodged or dislocated 35
Failure to reset 33
Loss of Data 32
Positioning Issue 30
Naturally worn 28
No flow 26
Material deformation 26
Difficult to remove 24
Incorrect display 20
Use of Incorrect Control Settings 20
Looping 19
Connection issue 19
Programming issue 17
Total Device Problems 63351

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 1 1 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Animas Corporation II Jan-30-2015
2 Medtronic MiniMed II Apr-10-2013
3 Medtronic MiniMed Inc. II Dec-17-2015
4 Medtronic MiniMed Inc. II Aug-22-2014

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