TPLC - Total Product Life Cycle

• Device: glucose dehydrogenase, glucose
• Regulation Description: Glucose test system.
• Product Code: LFR
• Regulation Number: 862.1345
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	5
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	4
BAYER
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	4
BOEHRINGER
	SUBSTANTIALLY EQUIVALENT	9
DOW
	SUBSTANTIALLY EQUIVALENT	2
EMD
	SUBSTANTIALLY EQUIVALENT	3
NOVA
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	2
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	8
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	3
TAIDOC TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	4
TRACE SCIENTIFIC LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Incorrect or inadequate result	20839
Use of Incorrect Control Settings	11027
Loss of Data	4877
Incorrect or inadequate test results	2691
Computer operating system issue	2520
Battery issue	2234
Reset issue	2233
Improper device output	1086
Device expiration issue	358
Mislabeled	333
Expiration date error	180
Device displays error message	165
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	79
Replace	77
Unable to obtain readings	49
Self-activation or keying	28
High test results	24
Output above specifications	23
No Known Device Problem	22
Retraction problem	19
Use of Device Issue	16
Patient-device incompatibility	16
Application interface becomes non-functional or program exits abnormally	15
Battery failure	13
Moisture damage	12
Fracture	12
False device output	10
Improper or incorrect procedure or method	10
Interference	9
Low battery	8
Incorrect measurement	8
Break	7
Connection issue	7
Low test results	7
Poor quality image	6
Device operates differently than expected	6
Unknown (for use when the device problem is not known)	6
Incorrect display	5
Smoking	4
Measurement system incompatibility	4
Programming issue	3
Interference with monitoring device	3
Device Issue	3
Charging issue	3
Error or warning message, failure to produce	3
Detachment of device component	3
Kinked	3
Erratic display	3
High Readings	2
Melted	2
Shipping damage or problem	2
No Information	2
Overfill	2
Buckled material	2
Detachment of device or device component	2
Therapeutic or diagnostic output failure	2
Contamination during use	2
Cooling system, failure of	2
Display misread	2
Failure to power-up	2
Labeling, missing	1
Material opacification	1
Material fragmentation	1
False reading from device non-compliance	1
Fire	1
Coolant, contraindicated	1
Burst	1
Continuous mode failure	1
Protective measure issue	1
Application program issue	1
Communication or transmission issue	1
Device Contamination with biological material	1
Improper alarm	1
Emergency stop button or switch failure	1
Corrosion	1
High sensing threshold	1
Sharp/jagged/rough/etched/scratched	1
Aspiration issue	1
Device contamination with blood or blood product	1
Failure to infuse	1
Tear, rip or hole in device packaging	1
Miscalibration	1
Not Applicable	1
Lens (IOL), migration of intraocular	1
No display or display failure	1
Excessive Manipulation	1
Failure to disconnect	1
Inadequate storage	1
Interlock(s), failure of	1
Disinfection or Sterilization Issue at User Location	1
Premature indicator activation	1
Radiation Underexposure	1
Elective replacement	1
Insulation, detached	1
Device alarm system issue	1
Total Device Problems	49724

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