TPLC - Total Product Life Cycle

show TPLC since

Device	real time nucleic acid amplification system
Definition	The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.
Product Code	OOI
Regulation Number	862.2570
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	473	473
Program or Algorithm Execution Problem	316	316
Incorrect, Inadequate or Imprecise Result or Readings	282	282
Device Dislodged or Dislocated	194	194
Fluid/Blood Leak	144	144
Mechanical Problem	53	53
False Negative Result	48	48
Unable to Obtain Readings	30	30
Structural Problem	26	26
Smoking	19	19
No Apparent Adverse Event	15	15
Sparking	7	7
Temperature Problem	6	6
Human-Device Interface Problem	5	5
Detachment of Device or Device Component	5	5
Patient Data Problem	4	4
Unintended Electrical Shock	3	3
Leak/Splash	3	3
Overheating of Device	2	2
Fire	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Output Problem	2	2
Non Reproducible Results	2	2
Difficult to Open or Close	2	2
Device Fell	2	2
Ejection Problem	1	1
Physical Resistance/Sticking	1	1
Insufficient Information	1	1
Data Problem	1	1
Protective Measures Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unintended Movement	1	1
Mechanical Jam	1	1
Patient-Device Incompatibility	1	1
Device Ingredient or Reagent Problem	1	1
Device Markings/Labelling Problem	1	1
Device Damaged by Another Device	1	1
Fumes or Vapors	1	1
Crack	1	1
No Display/Image	1	1
Electrical /Electronic Property Problem	1	1
Melted	1	1
Nonstandard Device	1	1
Device Emits Odor	1	1
Failure to Power Up	1	1
Use of Device Problem	1	1
Volume Accuracy Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Low Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1495	1495
No Consequences Or Impact To Patient	108	108
No Known Impact Or Consequence To Patient	19	19
No Patient Involvement	17	17
Insufficient Information	9	9
Abrasion	4	4
Electric Shock	2	2
Test Result	2	2
No Information	1	1
Limb Fracture	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Head Injury	1	1
Pain	1	1
Swelling	1	1
Tingling	1	1
Discomfort	1	1
Numbness	1	1
Pallor	1	1