TPLC - Total Product Life Cycle

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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	44	44
High Test Results	31	31
Low Readings	15	15
Mechanical Problem	14	14
Insufficient Information	13	13
Use of Device Problem	12	12
Non Reproducible Results	11	11
Adverse Event Without Identified Device or Use Problem	8	8
High Readings	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Incorrect Measurement	5	5
Erratic Results	3	3
Computer Software Problem	3	3
Output Problem	3	3
Smoking	3	3
Unable to Obtain Readings	2	2
Installation-Related Problem	2	2
No Apparent Adverse Event	2	2
Improper Chemical Reaction	2	2
Improper or Incorrect Procedure or Method	2	2
Mechanical Jam	2	2
Calibration Problem	2	2
Chemical Problem	1	1
Unexpected Shutdown	1	1
Material Fragmentation	1	1
Improper Flow or Infusion	1	1
Component Misassembled	1	1
Electrical Shorting	1	1
Appropriate Term/Code Not Available	1	1
Failure to Calibrate	1	1
Overheating of Device	1	1
Device Contamination with Body Fluid	1	1
Defective Component	1	1
Therapeutic or Diagnostic Output Failure	1	1
Misassembled During Installation	1	1
Thermal Decomposition of Device	1	1
Sharp Edges	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	113	113
No Known Impact Or Consequence To Patient	20	20
No Consequences Or Impact To Patient	19	19
Death	3	3
Insufficient Information	3	3
Laceration(s)	3	3
Test Result	2	2
Injury	2	2
Unspecified Infection	1	1
Electric Shock	1	1
Joint Dislocation	1	1
Bone Fracture(s)	1	1
Abrasion	1	1
Cardiac Arrest	1	1
Muscle/Tendon Damage	1	1