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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 1

Device Problems
Device displays error message 19616
Device operates differently than expected 4380
Device inoperable 2963
Structural problem 2917
Pumping stopped 2587
No Known Device Problem 2302
Wireless communication issue 1873
No display or display failure 1684
Incorrect measurement 1411
Image display error 1296
Crack 1174
Moisture damage 919
Mechanical issue 918
Occlusion within device 910
Charging issue 838
Battery issue 751
Fail-safe mechanism issue 736
Break 714
Use of Device Issue 677
Failure to deliver 508
Moisture or humidity problem 473
Filling problem 464
Prompts will not clear 460
Failure to prime 450
Self-activation or keying 442
Invalid sensing 424
Electrical issue 408
Sticking 396
Device alarm system issue 390
Improper or incorrect procedure or method 378
Blockage within device or device component 353
Failure to read input signal 339
Material Protrusion 331
Application interface becomes non-functional or program exits abnormally 256
Loss of power 249
Scratched material 247
Loose or intermittent connection 229
Component falling 225
Detachment of device component 214
Fluid leak 212
Premature discharge of battery 211
Component missing 200
Failure to sense 195
Reset issue 192
Retraction problem 187
Improper flow or infusion 182
Leak 169
No Information 157
Device stops intermittently 155
Noise, Audible 151
Inappropriate or unexpected reset 146
Inaccurate delivery 144
Failure to power-up 131
False alarm 125
Device Issue 118
Poor quality image 113
Electro-magnetic interference (EMI) 104
Difficult or delayed activation 101
Date-related software issue 92
Low battery 86
Failure of device to self-test 81
Temperature issue 69
Erratic display 68
Excess flow or overinfusion 67
Physical resistance 67
Device sensing issue 67
Bent 66
Fitting problem 66
Defective Alarm 64
Vibration 64
Malposition of device 63
Slippage of device or device component 59
Unintended collision 59
Data Issue 59
Out-of-box failure 58
Insufficient flow or underinfusion 56
Air leak 51
Infusion or flow issue 50
Communication or transmission issue 48
Power source issue 48
Unable to obtain readings 48
Material discolored 47
Corrosion 46
Detachment of device or device component 45
High test results 44
Disconnection 36
Dislodged or dislocated 35
Failure to reset 33
Not audible alarm 32
Loss of Data 32
Positioning Issue 30
Naturally worn 28
Material deformation 26
No flow 26
Difficult to remove 24
Use of Incorrect Control Settings 20
Incorrect display 20
Looping 19
Connection issue 19
Programming issue 17
Total Device Problems 60930

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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