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	45	45
High Test Results	33	33
Low Readings	16	16
Mechanical Problem	13	13
Insufficient Information	13	13
Use of Device Problem	12	12
Non Reproducible Results	10	10
Adverse Event Without Identified Device or Use Problem	8	8
High Readings	7	7
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Incorrect Measurement	5	5
Output Problem	3	3
Erratic Results	3	3
Smoking	3	3
Computer Software Problem	3	3
Unable to Obtain Readings	2	2
Calibration Problem	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
Chemical Problem	1	1
Unexpected Shutdown	1	1
Device Contamination with Body Fluid	1	1
Communication or Transmission Problem	1	1
Defective Component	1	1
Therapeutic or Diagnostic Output Failure	1	1
Misassembled During Installation	1	1
Material Fragmentation	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
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	116	116
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
Hematuria	1	1
Bone Fracture(s)	1	1
Abrasion	1	1
Cardiac Arrest	1	1
Electrolyte Imbalance	1	1
Muscle/Tendon Damage	1	1