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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device artificial pancreas device system, threshold suspend
Definition An artificial pancreas system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.
Product CodeOZO
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 0 0 3 32 35 21

Device Problems
Device displays error message 2216
Device operates differently than expected 559
Device inoperable 517
No display or display failure 375
Break 229
Crack 181
Component missing 177
Bent 158
Incorrect or inadequate test results 131
Incorrect or inadequate result 112
Moisture or humidity problem 105
Sticking 104
Failure to deliver 99
Device alarm system issue 91
Moisture damage 85
No Information 83
Detachment of device component 78
Improper or incorrect procedure or method 76
Battery issue 76
Loss of power 69
No Known Device Problem 68
Calibration error 65
Application interface becomes non-functional or program exits abnormally 63
Component falling 60
Self-activation or keying 59
Scratched material 56
Communication or transmission issue 53
False reading from device non-compliance 51
Noise, Audible 51
Retraction problem 46
Failure to power-up 35
Low battery 34
Prompts will not clear 34
Difficult to remove 32
Reset issue 32
Poor quality image 29
Device stops intermittently 27
Difficult or delayed activation 25
Connection issue 25
Failure of device to self-test 24
Loss of threshold 24
Loose or intermittent connection 24
Failure to prime 24
Image display error 23
Fluid leak 22
Difficult to insert 22
Device sensing issue 21
Inaccurate delivery 20
High test results 20
Material Protrusion 18
Low readings 17
Material deformation 17
Unintended collision 17
Electro-magnetic interference (EMI) 17
Device or device fragments location unknown 16
Inappropriate or unexpected reset 14
Vibration 14
Corrosion 14
Premature discharge of battery 14
Failure to Adhere or Bond 14
Excess flow or overinfusion 14
Leak 13
Detachment of device or device component 13
Naturally worn 13
Calibration issue 12
Slippage of device or device component 12
Low test results 10
Dislodged or dislocated 10
Improper flow or infusion 10
Positioning Issue 10
Mechanical issue 9
Unable to obtain readings 9
Material separation 7
Kinked 7
Material discolored 7
Disconnection 7
Erratic display 7
Split 7
Malposition of device 7
Mechanical jam 7
Electromagnetic compatibility issue 6
Device contamination with blood or blood product 6
Air leak 6
Failure to reset 6
False alarm 5
Material integrity issue 5
Infusion or flow issue 4
Computer software issue 4
Data Issue 4
Power source issue 4
No flow 3
No code available 3
Intermittent continuity 3
Incorrect display 3
Failure to read input signal 3
Pumping stopped 3
Failure to shut off 3
Failure to fire 3
Failure to calibrate 3
Failure to advance 2
Total Device Problems 7032

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