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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 2017
11 33 35 37 24 31 29 40 45 52 4

Device Problems
Device displays error message 38177
Device operates differently than expected 30099
Wireless communication issue 29390
Invalid sensing 17204
Use of Device Issue 13093
Not audible alarm 9550
Defective Alarm 4419
No Known Device Problem 1827
Inappropriate or unexpected reset 1788
Detachment of device component 1297
Device inoperable 1182
Component missing 958
Structural problem 757
Incorrect display 427
Image display error 313
Fracture 276
Break 236
Device, or device fragments remain in patient 222
Failure to power-up 211
Poor quality image 207
Overheating of device or device component 190
Fail-safe mechanism issue 168
Low battery 131
No display or display failure 108
Normal 100
Data Issue 89
Electrical issue 85
Crack 84
Moisture damage 80
Incorrect measurement 80
Failure to read input signal 66
Operating system version or upgrade problem 53
Premature discharge of battery 49
Communication or transmission issue 42
Device Issue 41
Failure to prime 39
Incorrect or inadequate test results 32
Loss of power 30
No device output 29
Output issue 29
Material fragmentation 28
Loss of or failure to bond 28
Self-activation or keying 25
Imprecision 24
Detachment of device or device component 23
High test results 17
Inappropriate prompts 17
Component(s), broken 17
Connection issue 16
Improper alarm 16
Battery issue 15
Failure to Adhere or Bond 15
Failure to sense 15
Device stops intermittently 14
Failure to charge 14
Inaccurate delivery 13
Improper or incorrect procedure or method 13
Temperature issue 11
Mechanical issue 11
Retraction problem 10
Bent 10
Sticking 9
Intermittent continuity 8
No Information 8
Improper device output 7
Date-related software issue 7
Low audible alarm 7
Device alarm system issue 7
Incorrect or inadequate result 7
Loss of Data 6
Device sensing issue 5
Vibration 5
No voice prompts 5
Blockage within device or device component 5
Corrosion 5
Calibration error 4
Device handling issue 4
Issue with displayed error message 3
Power source issue 3
Charging issue 3
False reading from device non-compliance 3
Unable to obtain readings 3
Inappropriate shock 3
Size incorrect for patient 3
Occlusion within device 2
Radio signal problem 2
User used incorrect product for intended use 2
Delivery system failure 2
Computer operating system issue 2
Calibration issue 2
Low test results 2
Moisture or humidity problem 2
Sediment, precipitate or deposit in device or device ingredient 1
Optical issue 1
Output below specifications 1
Material deformation 1
Material Distortion 1
Failure to shut off 1
Foreign material present in device 1
High Readings 1
Total Device Problems 153654

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 1 0
Class II 0 0 1 1 0 0 0 1 1 0 0
Class III 0 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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