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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 2

Device Problems
Device displays error message 33832
Device operates differently than expected 29848
Wireless communication issue 23308
Invalid sensing 13458
Use of Device Issue 10793
Not audible alarm 9034
Defective Alarm 3896
No Known Device Problem 1644
Detachment of device component 1182
Inappropriate or unexpected reset 1151
Device inoperable 996
Component missing 819
Structural problem 528
Incorrect display 375
Fracture 275
Image display error 243
Device, or device fragments remain in patient 222
Poor quality image 207
Break 200
Failure to power-up 197
Overheating of device or device component 163
Fail-safe mechanism issue 112
Normal 100
No display or display failure 94
Low battery 93
Data Issue 89
Crack 84
Moisture damage 65
Electrical issue 65
Incorrect measurement 60
Operating system version or upgrade problem 53
Failure to read input signal 43
Communication or transmission issue 42
Premature discharge of battery 35
Incorrect or inadequate test results 32
Loss of power 30
Device Issue 29
No device output 29
Output issue 29
Failure to prime 29
Loss of or failure to bond 28
Material fragmentation 28
Self-activation or keying 25
Imprecision 24
Detachment of device or device component 22
Component(s), broken 17
Inappropriate prompts 17
High test results 17
Improper alarm 16
Failure to sense 15
Failure to Adhere or Bond 15
Battery issue 15
Improper or incorrect procedure or method 14
Device stops intermittently 14
Connection issue 14
Failure to charge 14
Inaccurate delivery 11
Mechanical issue 11
Bent 10
Sticking 9
No Information 8
Intermittent continuity 8
Improper device output 7
Temperature issue 7
Incorrect or inadequate result 7
Low audible alarm 6
Device alarm system issue 6
Loss of Data 6
Retraction problem 6
Corrosion 5
Device sensing issue 5
Vibration 5
Date-related software issue 5
No voice prompts 5
Calibration error 4
Blockage within device or device component 4
Size incorrect for patient 3
Unable to obtain readings 3
False reading from device non-compliance 3
Inappropriate shock 3
Power source issue 3
Charging issue 3
Occlusion within device 2
Moisture or humidity problem 2
Calibration issue 2
Device expiration issue 2
Low test results 2
Computer operating system issue 2
Device handling issue 2
User used incorrect product for intended use 2
Radio signal problem 2
Delayed alarm 1
Failure to deploy 1
Failure to separate 1
Application program issue 1
Incomplete or missing packaging 1
Material deformation 1
Foreign material present in device 1
Sensing intermittently 1
Optical issue 1
Total Device Problems 133959

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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