TPLC - Total Product Life Cycle

• Device: pump, infusion, insulin
• Regulation Description: Infusion pump.
• Product Code: LZG
• Regulation Number: 880.5725
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	3
ANIMAS
	SUBSTANTIALLY EQUIVALENT	7
DISETRONIC MEDICAL SYSTEMS, INC.
	SE SUBJECT TO TRACKING REG	1
	SUBSTANTIALLY EQUIVALENT	9
GUIDANT CORP
	SUBSTANTIALLY EQUIVALENT	1
INSULET CORP.
	SUBSTANTIALLY EQUIVALENT	4
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
MEDINGO LTD.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SE SUBJECT TO TRACKING REG	5
	SUBSTANTIALLY EQUIVALENT	10
NILIMEDIX LTD.
	SUBSTANTIALLY EQUIVALENT	1
NIPRO CORP
	SUBSTANTIALLY EQUIVALENT	3
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	3
SMITHS
	SUBSTANTIALLY EQUIVALENT	3
SOOIL DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
VALERITAS, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Unknown (for use when the device problem is not known)	767
Dislodged or dislocated	235
No Information	232
Bent	193
Kinked	170
Difficult to insert	66
No Known Device Problem	57
Deployment issue	25
Component(s), broken	18
Failure to deploy	18
Fluid leak	16
Image display error	15
Improper or incorrect procedure or method	14
No display or display failure	11
Inaccurate delivery	11
Failure to power-up	11
Crack	10
Incorrect measurement	10
Leak	10
Low test results	10
Failure to fire	8
Retraction problem	8
Use of Device Issue	8
Device displays error message	8
Detachment of device or device component	7
Unintended movement	5
Moisture damage	5
Excess flow or overinfusion	5
Device operates differently than expected	4
Infusion or flow issue	4
Battery failure	4
High test results	4
Incorrect or inadequate test results	4
Incorrect or inadequate result	3
Tip breakage	3
Bleed back	3
Communication or transmission issue	3
Failure to prime	2
Sensor problems	2
False reading from device non-compliance	2
Hole in material	2
Alarm, audible	2
Device alarm system issue	2
Device damaged prior to use	2
Replace	2
Failure to disconnect	2
Defective component	2
Alarm system, failure of message-service	2
Incorrect display	2
Loss of or failure to bond	2
Break	2
No code available	2
Noise, Audible	2
Torn material	2
Suspect EMI	1
Other (for use when an appropriate device code cannot be identified)	1
Component missing	1
Not audible alarm	1
Filling problem	1
Degraded	1
Shelf life exceeded	1
Nonstandard device or device component	1
Premature explantation	1
Failure to Adhere or Bond	1
Corrosion	1
Loose	1
Membrane leak(s)	1
Inappropriate shock	1
Sticking	1
Syringe, hole(s) in	1
Data Issue	1
Material deformation	1
Failure to advance	1
Positioning Issue	1
Insufficient flow or underinfusion	1
High Readings	1
Connection issue	1
Device disinfection or sterilization issue	1
Failure, intermittent	1
Occlusion within device	1
Increase in pressure	1
Loose or intermittent connection	1
Delayed alarm	1
Use of Incorrect Control Settings	1
Loss of power	1
Telemetry discrepancy	1
Device Issue	1
Wrinkled	1
Folded	1
Material twisted	1
Mechanical jam	1
Repair	1
Total Device Problems	2057

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	1	0	0	0	0	1
Class II	1	3	3	1	2	2	0
Class III	0	0	0	1	0	0	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Animas Corporation	I	Apr-03-2013
2	Animas Corporation	III	Feb-17-2013
3	Animas Corporation	II	Oct-02-2012
4	Animas Corporation	II	Apr-06-2012
5	Animas Corporation	II	Aug-12-2011
6	Animas Corporation	II	May-10-2011
7	Animas Corporation	II	Sep-10-2010
8	Animas Corporation	III	May-08-2010
9	Animas Corporation	II	Mar-03-2009
10	Animas Corporation	I	Nov-25-2008
11	Animas Corporation	II	Nov-07-2008
12	Disetronic Medical Systems, Inc.	II	May-26-2009
13	Medtronic MiniMed	II	Jul-07-2007
14	Smiths Medical MD, Inc.	II	Apr-16-2009
15	Smiths Medical MD, Inc.	II	Sep-01-2008
16	Smiths Medical MD, Inc.	II	Aug-15-2008