TPLC - Total Product Life Cycle

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Device	electrode, ion specific, potassium
Regulation Description	Potassium test system.
Product Code	CEM
Regulation Number	862.1600
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	43	43
High Test Results	34	34
Mechanical Problem	10	10
Non Reproducible Results	10	10
Insufficient Information	9	9
Use of Device Problem	9	9
Low Readings	9	9
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Adverse Event Without Identified Device or Use Problem	7	7
High Readings	6	6
Incorrect Measurement	5	5
Output Problem	4	4
Erratic Results	3	3
Smoking	2	2
Unable to Obtain Readings	2	2
Calibration Problem	2	2
Installation-Related Problem	2	2
No Apparent Adverse Event	2	2
Computer Software Problem	2	2
Improper Chemical Reaction	2	2
Improper or Incorrect Procedure or Method	2	2
Mechanical Jam	2	2
Chemical Problem	1	1
Defective Component	1	1
Therapeutic or Diagnostic Output Failure	1	1
Misassembled During Installation	1	1
Improper Flow or Infusion	1	1
Thermal Decomposition of Device	1	1
Sharp Edges	1	1
Electrical Shorting	1	1
Component Misassembled	1	1
Failure to Calibrate	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	118	118
No Consequences Or Impact To Patient	11	11
No Known Impact Or Consequence To Patient	8	8
Insufficient Information	3	3
Laceration(s)	3	3
Injury	2	2
Unspecified Infection	1	1
Joint Dislocation	1	1
Electric Shock	1	1
Hematuria	1	1
Bone Fracture(s)	1	1
Abrasion	1	1
Cardiac Arrest	1	1
Electrolyte Imbalance	1	1
Muscle/Tendon Damage	1	1