TPLC - Total Product Life Cycle

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Device	test, equipment, automated bloodborne pathogen
Product Code	MZA
Device Class	Not Classified

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	33	34
Leak/Splash	9	9
Thermal Decomposition of Device	9	9
Incorrect, Inadequate or Imprecise Result or Readings	8	9
Sparking	6	6
False Negative Result	6	6
Mechanical Problem	3	3
Smoking	3	3
Output Problem	2	3
Use of Device Problem	2	2
High Readings	1	1
Misassembled During Installation	1	1
Sharp Edges	1	1
High Test Results	1	1
Optical Problem	1	1
Data Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Installation-Related Problem	1	1
Computer Software Problem	1	1
Difficult to Open or Close	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Jam	1	1
Fluid/Blood Leak	1	1
Low Test Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	66	67
Insufficient Information	3	3
Needle Stick/Puncture	2	2
No Consequences Or Impact To Patient	2	2
Damage to Ligament(s)	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Exposure to Body Fluids	1	1
Laceration(s)	1	1
Eye Injury	1	1
Eye Pain	1	1