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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device glucose dehydrogenase, glucose
Regulation Description Glucose test system.
Product CodeLFR
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 10
BAYER
  SUBSTANTIALLY EQUIVALENT 4
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 9
DOW
  SUBSTANTIALLY EQUIVALENT 2
EMD
  SUBSTANTIALLY EQUIVALENT 3
NOVA
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 12
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 21195
Use of Incorrect Control Settings 11027
Incorrect or inadequate test results 5640
Loss of Data 4877
Computer operating system issue 2520
Battery issue 2235
Reset issue 2233
Improper device output 1095
Device expiration issue 358
Mislabeled 333
High test results 297
Low test results 291
Expiration date error 180
Device displays error message 169
Device markings issue 164
Other (for use when an appropriate device code cannot be identified) 123
Crack 114
Malfunction 113
Measurements, inaccurate 82
Shelf life exceeded 81
Replace 77
Unable to obtain readings 50
Self-activation or keying 28
No Known Device Problem 26
Output above specifications 23
Retraction problem 20
Use of Device Issue 18
Failure to power-up 17
Patient-device incompatibility 16
Application interface becomes non-functional or program exits abnormally 15
Device operates differently than expected 13
Battery failure 13
Moisture damage 13
Fracture 12
Improper or incorrect procedure or method 12
False device output 10
Interference 9
Incorrect measurement 9
Low battery 8
Break 7
Output issue 7
Connection issue 7
Unknown (for use when the device problem is not known) 6
Poor quality image 6
Incorrect display 5
High Readings 5
Unexpected therapeutic results 5
Measurement system incompatibility 4
Smoking 4
Image display error 4
Device Issue 4
Detachment of device component 3
Error or warning message, failure to produce 3
No Information 3
Erratic display 3
Kinked 3
Interference with monitoring device 3
Programming issue 3
Charging issue 3
Contamination during use 2
Display misread 2
False reading from device non-compliance 2
Melted 2
Overfill 2
Therapeutic or diagnostic output failure 2
No display or display failure 2
Buckled material 2
Shipping damage or problem 2
Burn of device or device component 2
Detachment of device or device component 2
Unintended movement 2
Cooling system, failure of 2
Device Contamination with biological material 1
Improper alarm 1
Sharp/jagged/rough/etched/scratched 1
Leak 1
Aspiration issue 1
Failure to infuse 1
Material fragmentation 1
Application program issue 1
Protective measure issue 1
Material opacification 1
User used incorrect product for intended use 1
Lens (IOL), migration of intraocular 1
Defective item 1
Inaccurate delivery 1
Premature indicator activation 1
Loose or intermittent connection 1
Radiation Underexposure 1
Device disinfection or sterilization issue 1
Failure to disconnect 1
Device alarm system issue 1
Not Applicable 1
No code available 1
Leak(s) from hydraulic bed system 1
Disinfection or Sterilization Issue at User Location 1
Insulation, detached 1
Interlock(s), failure of 1
Intermittent continuity 1
Data back-up problem 1
Total Device Problems 53658

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 1 0 0 0 0 0 0 0 0 0 0
Class II 0 2 1 0 1 1 0 0 0 1 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 Sep-11-2008
2 Bayer Healthcare LLC II Mar-13-2008
3 Bayer Healthcare LLC I Jul-03-2007
4 Bayer Healthcare, LLC II Sep-19-2011
5 Lifescan Inc II Apr-02-2012
6 Roche Diagnostics Corp. II Aug-11-2009
7 Roche Diagnostics Operations, Inc. II Mar-14-2016

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