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	46	46
High Test Results	34	34
Non Reproducible Results	13	13
Incorrect, Inadequate or Imprecise Result or Readings	11	11
Mechanical Problem	10	10
Insufficient Information	9	9
Use of Device Problem	9	9
Low Readings	9	9
High Readings	8	8
Adverse Event Without Identified Device or Use Problem	7	7
Output Problem	6	6
Erratic Results	3	3
Smoking	2	2
Calibration Problem	2	2
Incorrect Measurement	2	2
Installation-Related Problem	2	2
Computer Software Problem	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
No Apparent Adverse Event	1	1
Component Misassembled	1	1
Failure to Calibrate	1	1
Appropriate Term/Code Not Available	1	1
Inaccurate Information	1	1
Improper Chemical Reaction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	130	130
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