TPLC - Total Product Life Cycle

• Device: electrode, ion specific, potassium
• Product Code: CEM
• Regulation Number: 862.1600
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIAMOND DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
DIAMOND DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EPOCAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INPECO S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
INSTRUMENTATION LABORATORY CO.
	SUBSTANTIALLY EQUIVALENT	1
MEDICA CORP.
	SUBSTANTIALLY EQUIVALENT	1
MEDICA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
1.  K220396  EasyStat 300
ORTHO-CLINICAL DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
POLYMEDCO, INC.
	SUBSTANTIALLY EQUIVALENT	1
RADIOMETER MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1
RANDOX LABORATORIES LTD.
	SUBSTANTIALLY EQUIVALENT	1
TOKYO BOEKI MEDISYS INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	4	4
2015	7	7
2016	6	6
2017	32	32
2018	13	13
2019	25	25
2020	27	27
2021	18	18
2022	16	16
2023	32	32
2024	32	32

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	58	58
High Test Results	53	53
Incorrect, Inadequate or Imprecise Result or Readings	17	17
Low Readings	14	14
Insufficient Information	13	13
Mechanical Problem	13	13
Use of Device Problem	12	12
Adverse Event Without Identified Device or Use Problem	8	8
High Readings	7	7
Non Reproducible Results	7	7
Incorrect Or Inadequate Test Results	5	5
Smoking	3	3
Output Problem	3	3
Erratic Results	3	3
Calibration Problem	2	2
Improper Chemical Reaction	2	2
Incorrect Measurement	2	2
Improper or Incorrect Procedure or Method	2	2
Computer Software Problem	2	2
False Device Output	1	1
False Reading From Device Non-Compliance	1	1
Material Fragmentation	1	1
Overheating of Device	1	1
Unable to Obtain Readings	1	1
Break	1	1
Thermal Decomposition of Device	1	1
Defective Component	1	1
Device Contamination with Body Fluid	1	1
Failure to Calibrate	1	1
Installation-Related Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Mechanical Jam	1	1
Chemical Problem	1	1
Electrical Shorting	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Component Misassembled	1	1
Sharp Edges	1	1
Unexpected Shutdown	1	1
Misassembled During Installation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	96	96
No Known Impact Or Consequence To Patient	60	60
No Consequences Or Impact To Patient	37	37
Test Result	4	4
Laceration(s)	3	3
Death	3	3
Injury	2	2
Insufficient Information	2	2
No Code Available	1	1
Muscle/Tendon Damage	1	1
Joint Dislocation	1	1
Electric Shock	1	1
Bone Fracture(s)	1	1
Unspecified Infection	1	1
Abrasion	1	1
Exposure to Body Fluids	1	1
Cardiac Arrest	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	II	Jun-03-2020
2	Abbott Laboratories	II	Jun-27-2015
3	Beckman Coulter Inc.	II	Aug-10-2013
4	Beckman Coulter Inc.	II	Nov-19-2012
5	Beckman Coulter Inc.	II	Apr-26-2011
6	Beckman Coulter Inc.	II	Mar-09-2011
7	Epocal	II	Feb-06-2009
8	Inpeco S.A.	II	Dec-15-2023
9	Inpeco S.A.	II	May-04-2023
10	Inpeco S.A.	II	Oct-12-2021
11	Inpeco S.A.	II	Nov-06-2020
12	Inpeco S.A.	II	Sep-16-2020
13	Inpeco S.A.	II	Jun-01-2020
14	Inpeco S.A.	II	May-26-2020
15	Inpeco S.A.	II	May-14-2020
16	Inpeco S.A.	II	Nov-16-2016
17	Instrumentation Laboratory Co.	I	Jul-21-2011
18	Ortho-Clinical Diagnostics	II	Nov-01-2019
19	Ortho-Clinical Diagnostics	III	Jun-27-2013
20	Radiometer America Inc	II	Aug-22-2019
21	Radiometer America Inc	II	Apr-28-2011
22	Radiometer America Inc	II	Feb-02-2011
23	Radiometer Medical ApS	II	Jun-15-2021
24	Radiometer Medical ApS	II	Apr-22-2020
25	Randox Laboratories Ltd.	II	Oct-31-2023
26	Randox Laboratories Ltd.	II	Jul-26-2021
27	Roche Diagnostics Corporation	II	May-03-2018
28	Siemens Healthcare Diagnostics, Inc.	II	Apr-07-2015
29	Siemens Healthcare Diagnostics, Inc.	II	Oct-25-2010