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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 4

Device Problems
Device displays error message 20112
Device operates differently than expected 4485
Structural problem 3777
Pumping stopped 3055
Device inoperable 2989
No Known Device Problem 2589
Wireless communication issue 2193
No display or display failure 1759
Incorrect measurement 1733
Image display error 1647
Crack 1203
Mechanical issue 1098
Occlusion within device 1050
Moisture damage 1016
Charging issue 1009
Fail-safe mechanism issue 945
Battery issue 785
Use of Device Issue 756
Break 714
Electrical issue 512
Failure to deliver 507
Invalid sensing 506
Filling problem 506
Failure to prime 493
Prompts will not clear 485
Moisture or humidity problem 473
Self-activation or keying 442
Failure to read input signal 419
Device alarm system issue 400
Sticking 396
Blockage within device or device component 386
Improper or incorrect procedure or method 382
Material Protrusion 331
Premature discharge of battery 267
Application interface becomes non-functional or program exits abnormally 256
Loss of power 249
Scratched material 247
Loose or intermittent connection 244
Component falling 225
Failure to sense 225
Detachment of device component 224
Fluid leak 212
Component missing 210
Retraction problem 198
Reset issue 192
Improper flow or infusion 182
Leak 180
No Information 163
Inaccurate delivery 158
Device Issue 155
Device stops intermittently 155
Inappropriate or unexpected reset 153
Noise, Audible 151
False alarm 144
Date-related software issue 133
Failure to power-up 132
Poor quality image 114
Electro-magnetic interference (EMI) 104
Difficult or delayed activation 101
Temperature issue 89
Low battery 86
Failure of device to self-test 84
Physical resistance 81
Defective Alarm 80
Excess flow or overinfusion 71
Fitting problem 70
Bent 69
Erratic display 68
Device sensing issue 67
Vibration 64
Malposition of device 63
Data Issue 63
Insufficient flow or underinfusion 61
Out-of-box failure 60
Slippage of device or device component 59
Unintended collision 59
Detachment of device or device component 57
Communication or transmission issue 54
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 38
Not audible alarm 37
Dislodged or dislocated 35
Failure to reset 33
Loss of Data 32
Positioning Issue 30
Naturally worn 28
Material deformation 26
No flow 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 65970

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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