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)	766
No Information	206
Dislodged or dislocated	204
Bent	171
Kinked	145
Difficult to insert	56
No Known Device Problem	50
Deployment issue	23
Component(s), broken	18
Failure to deploy	16
Fluid leak	15
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
Leak	10
Device displays error message	8
Incorrect measurement	8
Use of Device Issue	8
Detachment of device or device component	7
Retraction problem	7
Failure to fire	7
Low test results	6
Moisture damage	5
Excess flow or overinfusion	5
Device operates differently than expected	4
Incorrect or inadequate test results	4
Battery failure	4
Bleed back	3
High test results	3
Tip breakage	3
Incorrect or inadequate result	3
Infusion or flow issue	3
Sensor problems	2
False reading from device non-compliance	2
Alarm, audible	2
Failure to prime	2
Communication or transmission issue	2
Alarm system, failure of message-service	2
Incorrect display	2
Loss of or failure to bond	2
Break	2
Torn material	2
Defective component	2
Device damaged prior to use	2
Replace	2
Device alarm system issue	2
Failure to disconnect	2
Positioning Issue	1
Failure, intermittent	1
Occlusion within device	1
Increase in pressure	1
Loose or intermittent connection	1
Insufficient flow or underinfusion	1
High Readings	1
Connection issue	1
Device disinfection or sterilization issue	1
Failure to Adhere or Bond	1
Corrosion	1
Loose	1
Inappropriate shock	1
Sticking	1
Data Issue	1
Failure to advance	1
Material deformation	1
Unintended movement	1
No code available	1
Noise, Audible	1
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
Shelf life exceeded	1
Nonstandard device or device component	1
Premature explantation	1
Repair	1
Delayed alarm	1
Use of Incorrect Control Settings	1
Hole in material	1
Loss of power	1
Telemetry discrepancy	1
Device Issue	1
Wrinkled	1
Mechanical jam	1
Total Device Problems	1907

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