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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sensor, glucose, invasive
Definition The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
Product CodeMDS
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
11 33 35 37 24 31 29 40 45 28

Device Problems
Device operates differently than expected 27785
Device displays error message 18127
Wireless communication issue 10496
Not audible alarm 6136
Use of Device Issue 5817
Invalid sensing 2657
Defective Alarm 1971
No Known Device Problem 986
Detachment of device component 790
Device inoperable 578
Component missing 413
Inappropriate or unexpected reset 402
Fracture 275
Device, or device fragments remain in patient 222
Poor quality image 207
Failure to power-up 136
Break 116
Overheating of device or device component 109
Normal 100
Data Issue 89
Crack 84
Incorrect display 57
Communication or transmission issue 39
No display or display failure 38
Incorrect or inadequate test results 32
Output issue 29
No device output 29
Loss of power 29
Loss of or failure to bond 28
Material fragmentation 27
Self-activation or keying 25
Operating system version or upgrade problem 25
Imprecision 24
Component(s), broken 17
Inappropriate prompts 17
High test results 17
Detachment of device or device component 15
Failure to Adhere or Bond 15
Device stops intermittently 14
Connection issue 14
Battery issue 12
Device Issue 12
Improper or incorrect procedure or method 11
Mechanical issue 11
Improper alarm 11
Bent 10
Sticking 9
Intermittent continuity 8
Incorrect or inadequate result 7
Improper device output 7
Low battery 7
Loss of Data 6
No Information 6
Device alarm system issue 6
Corrosion 5
Failure to charge 5
Moisture damage 5
Vibration 5
No voice prompts 5
Low audible alarm 4
Calibration error 4
Device sensing issue 4
False reading from device non-compliance 3
Failure to sense 3
Size incorrect for patient 3
User used incorrect product for intended use 2
Radio signal problem 2
Unable to obtain readings 2
Device expiration issue 2
Occlusion within device 2
Image display error 2
Calibration issue 2
Computer operating system issue 2
Low test results 2
Power source issue 2
Moisture or humidity problem 2
Device handling issue 2
Sediment, precipitate or deposit in device or device ingredient 1
Temperature issue 1
Optical issue 1
Output below specifications 1
Issue with displayed error message 1
Material deformation 1
Material Distortion 1
High Readings 1
Failure to separate 1
Device or device fragments location unknown 1
Patient-device incompatibility 1
Application program issue 1
Charging issue 1
Failure to shut off 1
Foreign material present in device 1
Difficult to insert 1
Loose or intermittent connection 1
Fire 1
Fluid leak 1
Application interface becomes non-functional or program exits abnormally 1
Failure to deploy 1
Disconnection 1
Erratic display 1
Total Device Problems 78203

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. II Apr-30-2010
2 Abbott Diabetes Care, Inc. II May-20-2009
3 Dexcom Inc I Apr-11-2016
4 Medtronic MiniMed Inc. II Aug-21-2015
5 Medtronic MiniMed Inc. II Aug-10-2014

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