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	44	46
High Test Results	34	36
Non Reproducible Results	14	15
Incorrect, Inadequate or Imprecise Result or Readings	14	14
Mechanical Problem	8	8
Insufficient Information	8	8
Output Problem	7	9
Use of Device Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
High Readings	4	4
Low Readings	4	6
Incorrect Measurement	3	4
Erratic Results	2	2
Calibration Problem	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	2
Defective Component	1	1
Therapeutic or Diagnostic Output Failure	1	1
Misassembled During Installation	1	1
Improper Flow or Infusion	1	2
Thermal Decomposition of Device	1	1
Sharp Edges	1	1
No Apparent Adverse Event	1	1
Failure to Calibrate	1	1
Appropriate Term/Code Not Available	1	1
Inaccurate Information	1	1
Improper Chemical Reaction	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	132	139
Insufficient Information	3	3
Joint Dislocation	1	1
Hematuria	1	1
Bone Fracture(s)	1	1
Abrasion	1	1
Cardiac Arrest	1	1
Electrolyte Imbalance	1	1
Laceration(s)	1	1
Muscle/Tendon Damage	1	1