TPLC - Total Product Life Cycle

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Device	electrode, ion based, enzymatic, creatinine
Product Code	CGL
Regulation Number	862.1225
Device Class	2

Premarket Reviews
Manufacturer	Decision
EPOCAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
NOVA BIOMEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	45	45
Non Reproducible Results	21	21
Incorrect Measurement	13	13
Low Test Results	13	13
False Positive Result	5	5
Low Readings	3	3
High Test Results	3	3
Erratic Results	3	3
Insufficient Information	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Use of Device Problem	2	2
Defective Component	2	2
Incorrect Or Inadequate Test Results	2	2
Device Operates Differently Than Expected	2	2
Fluid/Blood Leak	2	2
Smoking	1	1
Device Stops Intermittently	1	1
Display or Visual Feedback Problem	1	1
Application Program Problem: Dose Calculation Error	1	1
Electrical /Electronic Property Problem	1	1
False Negative Result	1	1
Device Operational Issue	1	1
Device Displays Incorrect Message	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	29	29
No Consequences Or Impact To Patient	20	20
No Information	16	16
No Known Impact Or Consequence To Patient	13	13
Insufficient Information	9	9
Cancer	6	6
No Code Available	4	4
Death	3	3
Abnormal Blood Gases	2	2
Abdominal Pain	2	2
Hematuria	2	2
No Patient Involvement	1	1
Diabetic Ketoacidosis	1	1
Breast Mass	1	1
Premature Labor	1	1
Sudden Cardiac Death	1	1
Claudication	1	1
Apnea	1	1
Breast Cancer	1	1
Cardiac Arrest	1	1
Pain	1	1
Peripheral Vascular Disease	1	1
Transient Ischemic Attack	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Point of Care Inc.	II	Nov-24-2010
2	Nova Biomedical Corporation	II	May-07-2009
3	Radiometer America Inc	II	Mar-18-2015
4	Radiometer America Inc	II	Feb-13-2012
5	Radiometer America Inc	II	Mar-05-2010