TPLC - Total Product Life Cycle

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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	543	543
Program or Algorithm Execution Problem	316	316
Incorrect, Inadequate or Imprecise Result or Readings	289	289
Device Dislodged or Dislocated	194	194
Fluid/Blood Leak	160	160
Mechanical Problem	53	53
False Negative Result	52	52
Unable to Obtain Readings	30	30
Structural Problem	29	29
Smoking	20	20
No Apparent Adverse Event	15	15
Human-Device Interface Problem	7	7
Sparking	7	7
Temperature Problem	6	6
Detachment of Device or Device Component	5	5
Patient Data Problem	4	4
Failure to Obtain Sample	3	3
Unintended Electrical Shock	3	3
Leak/Splash	3	3
Fire	3	3
Non Reproducible Results	2	2
Output Problem	2	2
Overheating of Device	2	2
Difficult to Open or Close	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Device Fell	2	2
Physical Resistance/Sticking	1	1
No Display/Image	1	1
Fumes or Vapors	1	1
Device Ingredient or Reagent Problem	1	1
Volume Accuracy Problem	1	1
Crack	1	1
Protective Measures Problem	1	1
Device Markings/Labelling Problem	1	1
Thermal Decomposition of Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Device Damaged by Another Device	1	1
Defective Component	1	1
Failure to Power Up	1	1
Use of Device Problem	1	1
Data Problem	1	1
Device Emits Odor	1	1
Ejection Problem	1	1
Low Readings	1	1
Melted	1	1
Nonstandard Device	1	1
Unintended Movement	1	1
Electrical /Electronic Property Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1601	1601
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	5	5
Electric Shock	2	2
Test Result	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Tingling	1	1
No Information	1	1
Head Injury	1	1
Pallor	1	1
Swelling	1	1
Discomfort	1	1
Numbness	1	1
Pain	1	1
Limb Fracture	1	1
Skin Tears	1	1