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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
0 0 0 0 0 0 0 1 1 7

Device Problems
Device displays error message 17714
Device operates differently than expected 3927
Device inoperable 2883
No display or display failure 1403
Crack 1013
Wireless communication issue 876
No Known Device Problem 788
Break 711
Pumping stopped 652
Failure to deliver 507
Battery issue 499
Moisture or humidity problem 473
Self-activation or keying 442
Moisture damage 421
Sticking 396
Improper or incorrect procedure or method 363
Device alarm system issue 359
Use of Device Issue 352
Material Protrusion 331
Prompts will not clear 293
Incorrect measurement 269
Application interface becomes non-functional or program exits abnormally 256
Loss of power 249
Scratched material 242
Failure to prime 241
Component falling 225
Mechanical issue 223
Fluid leak 212
Occlusion within device 208
Reset issue 192
Improper flow or infusion 182
Loose or intermittent connection 182
Component missing 182
Detachment of device component 177
Retraction problem 165
Device stops intermittently 155
No Information 154
Charging issue 153
Filling problem 148
Noise, Audible 145
Failure to power-up 125
Blockage within device or device component 111
Leak 108
Electro-magnetic interference (EMI) 104
Poor quality image 101
Difficult or delayed activation 101
Inaccurate delivery 93
Low battery 86
Image display error 85
Inappropriate or unexpected reset 80
Invalid sensing 76
Failure of device to self-test 73
Erratic display 68
Device sensing issue 67
Failure to sense 66
Vibration 64
Malposition of device 63
Bent 61
Unintended collision 59
Slippage of device or device component 59
Excess flow or overinfusion 58
Premature discharge of battery 55
Infusion or flow issue 50
Air leak 49
Unable to obtain readings 48
Power source issue 48
Corrosion 45
High test results 44
Material discolored 38
Data Issue 38
Dislodged or dislocated 35
Communication or transmission issue 33
Failure to reset 33
Loss of Data 31
Positioning Issue 30
False alarm 29
Naturally worn 28
No flow 26
Material deformation 26
Difficult to remove 24
Out-of-box failure 21
Date-related software issue 21
Use of Incorrect Control Settings 20
Incorrect display 20
Looping 19
Physical resistance 19
Connection issue 19
Programming issue 17
Insufficient flow or underinfusion 17
Intermittent continuity 15
Failure to charge 14
Fitting problem 14
Mechanical jam 14
Detachment of device or device component 14
Electromagnetic compatibility issue 13
Computer operating system issue 12
Temperature issue 12
Incorrect or inadequate result 12
Disconnection 12
Overheating of device or device component 11
Total Device Problems 41097

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