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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 45

Device Problems
Device displays error message 31421
Device operates differently than expected 29753
Wireless communication issue 20398
Invalid sensing 11618
Use of Device Issue 9870
Not audible alarm 8745
Defective Alarm 3646
No Known Device Problem 1558
Detachment of device component 1126
Inappropriate or unexpected reset 1011
Device inoperable 880
Component missing 768
Structural problem 379
Incorrect display 354
Fracture 275
Device, or device fragments remain in patient 222
Poor quality image 207
Image display error 198
Failure to power-up 193
Break 180
Overheating of device or device component 158
Normal 100
Fail-safe mechanism issue 92
Data Issue 89
Crack 84
No display or display failure 83
Low battery 61
Operating system version or upgrade problem 53
Moisture damage 51
Electrical issue 48
Communication or transmission issue 42
Incorrect measurement 37
Failure to read input signal 33
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
Premature discharge of battery 26
Self-activation or keying 25
Imprecision 24
Failure to prime 22
Device Issue 22
Detachment of device or device component 19
High test results 17
Inappropriate prompts 17
Component(s), broken 17
Improper alarm 16
Battery issue 15
Failure to Adhere or Bond 15
Failure to sense 15
Device stops intermittently 14
Connection issue 14
Improper or incorrect procedure or method 14
Failure to charge 13
Mechanical issue 11
Bent 10
Inaccurate delivery 10
Sticking 9
Intermittent continuity 8
No Information 8
Temperature issue 7
Improper device output 7
Incorrect or inadequate result 7
Device alarm system issue 6
Loss of Data 6
Device sensing issue 5
No voice prompts 5
Low audible alarm 5
Corrosion 5
Retraction problem 5
Vibration 5
Blockage within device or device component 4
Calibration error 4
False reading from device non-compliance 3
Size incorrect for patient 3
Unable to obtain readings 3
Charging issue 3
Power source issue 3
Moisture or humidity problem 2
Device handling issue 2
Date-related software issue 2
Calibration issue 2
Computer operating system issue 2
Low test results 2
Radio signal problem 2
User used incorrect product for intended use 2
Occlusion within device 2
Device expiration issue 2
Application interface becomes non-functional or program exits abnormally 1
Failure to deploy 1
Disconnection 1
Erratic display 1
Fire 1
Fluid leak 1
Difficult to insert 1
Loose or intermittent connection 1
Circuit Failure 1
Component falling 1
Total Device Problems 124386

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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