TPLC - Total Product Life Cycle

show TPLC since

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	38	38
High Test Results	28	28
Low Readings	14	14
Mechanical Problem	13	13
Insufficient Information	13	13
Use of Device Problem	12	12
Adverse Event Without Identified Device or Use Problem	8	8
High Readings	6	6
Non Reproducible Results	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Smoking	3	3
Erratic Results	3	3
Output Problem	3	3
Improper Chemical Reaction	2	2
Computer Software Problem	2	2
Incorrect Measurement	2	2
Improper or Incorrect Procedure or Method	2	2
Calibration Problem	2	2
Chemical Problem	1	1
Electrical Shorting	1	1
Defective Component	1	1
Device Contamination with Body Fluid	1	1
Failure to Calibrate	1	1
Thermal Decomposition of Device	1	1
Material Fragmentation	1	1
Overheating of Device	1	1
Unable to Obtain Readings	1	1
Installation-Related Problem	1	1
Mechanical Jam	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Misassembled During Installation	1	1
Appropriate Term/Code Not Available	1	1
Component Misassembled	1	1
Sharp Edges	1	1
Unexpected Shutdown	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	20	20
No Consequences Or Impact To Patient	19	19
Death	3	3
Laceration(s)	3	3
Insufficient Information	2	2
Test Result	2	2
Injury	2	2
Joint Dislocation	1	1
Electric Shock	1	1
Bone Fracture(s)	1	1
Unspecified Infection	1	1
Abrasion	1	1
Cardiac Arrest	1	1
Muscle/Tendon Damage	1	1