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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 21170
Use of Incorrect Control Settings 11027
Incorrect or inadequate test results 5107
Loss of Data 4877
Computer operating system issue 2520
Battery issue 2234
Reset issue 2233
Improper device output 1095
Device expiration issue 358
Mislabeled 333
High test results 242
Low test results 239
Expiration date error 180
Device displays error message 168
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
Patient-device incompatibility 16
Failure to power-up 15
Application interface becomes non-functional or program exits abnormally 15
Battery failure 13
Moisture damage 13
Device operates differently than expected 13
Improper or incorrect procedure or method 12
Fracture 12
False device output 10
Interference 9
Incorrect measurement 9
Low battery 8
Output issue 7
Connection issue 7
Break 7
Poor quality image 6
Unknown (for use when the device problem is not known) 6
Incorrect display 5
High Readings 5
Measurement system incompatibility 4
Device Issue 4
Unexpected therapeutic results 4
Smoking 4
Error or warning message, failure to produce 3
Erratic display 3
Interference with monitoring device 3
Kinked 3
Image display error 3
Detachment of device component 3
Charging issue 3
Programming issue 3
No Information 3
Therapeutic or diagnostic output failure 2
Unintended movement 2
Detachment of device or device component 2
Buckled material 2
Contamination during use 2
Burn of device or device component 2
Display misread 2
Cooling system, failure of 2
No display or display failure 2
False reading from device non-compliance 2
Melted 2
Shipping damage or problem 2
Overfill 2
Tear, rip or hole in device packaging 1
Device contamination with blood or blood product 1
Inaccurate delivery 1
Failure to infuse 1
Inadequate storage 1
Interlock(s), failure of 1
Lens (IOL), migration of intraocular 1
Material opacification 1
User used incorrect product for intended use 1
Incorrect software programming calculations 1
Fire 1
Elective replacement 1
Emergency stop button or switch failure 1
Insulation, detached 1
Material fragmentation 1
Leak 1
Leak(s) from hydraulic bed system 1
Loose or intermittent connection 1
Corrosion 1
Device alarm system issue 1
Coolant, contraindicated 1
Burst 1
Intermittent continuity 1
Continuous mode failure 1
Application program issue 1
Aspiration issue 1
Miscalibration 1
Sharp/jagged/rough/etched/scratched 1
Total Device Problems 52987

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 1 0 0 0 0 0 0 0 0 0
Class II 0 2 1 0 1 1 0 0 0 1
Class III 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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