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	40	40
Leak/Splash	23	23
Incorrect, Inadequate or Imprecise Result or Readings	14	14
Fluid/Blood Leak	7	7
Thermal Decomposition of Device	7	7
False Negative Result	6	6
Device Displays Incorrect Message	5	5
Sparking	3	3
High Test Results	3	3
Therapeutic or Diagnostic Output Failure	3	3
Appropriate Term/Code Not Available	3	3
Mechanical Problem	3	3
Moisture Damage	2	2
Defective Component	2	2
Calcified	2	2
Break	2	2
Display or Visual Feedback Problem	2	2
Data Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Output Problem	2	2
Protective Measures Problem	2	2
Activation, Positioning or Separation Problem	2	2
Detachment of Device or Device Component	2	2
Difficult to Open or Close	1	1
Failure to Auto Stop	1	1
Device Contamination with Chemical or Other Material	1	1
Installation-Related Problem	1	1
Mechanical Jam	1	1
Moisture or Humidity Problem	1	1
Low Test Results	1	1
High Readings	1	1
Sharp Edges	1	1
Device Fell	1	1
Misassembled During Installation	1	1
Computer Software Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Unintended Ejection	1	1
Smoking	1	1
Use of Device Problem	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	54	54
No Known Impact Or Consequence To Patient	26	26
No Consequences Or Impact To Patient	16	16
No Patient Involvement	8	8
No Code Available	4	4
Insufficient Information	3	3
Test Result	2	2
Superficial (First Degree) Burn	2	2
Injury	2	2
Needle Stick/Puncture	2	2
Caustic/Chemical Burns	2	2
Chemical Exposure	2	2
Exposure to Body Fluids	1	1
Eye Injury	1	1
Laceration(s)	1	1
Damage to Ligament(s)	1	1
Partial thickness (Second Degree) Burn	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1