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	589	589
Program or Algorithm Execution Problem	316	316
Incorrect, Inadequate or Imprecise Result or Readings	297	297
Device Dislodged or Dislocated	194	194
Fluid/Blood Leak	167	167
False Negative Result	53	53
Mechanical Problem	53	53
Unable to Obtain Readings	49	50
Structural Problem	30	30
Smoking	20	20
No Apparent Adverse Event	15	15
Sparking	7	7
Human-Device Interface Problem	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
Fire	3	3
Leak/Splash	3	3
Device Fell	2	2
Non Reproducible Results	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Output Problem	2	2
Overheating of Device	2	2
Difficult to Open or Close	2	2
Unintended Movement	1	1
Insufficient Information	1	1
Patient-Device Incompatibility	1	1
Device Markings/Labelling Problem	1	1
Defective Component	1	1
Therapeutic or Diagnostic Output Failure	1	1
Crack	1	1
Ejection Problem	1	1
Failure to Power Up	1	1
Use of Device Problem	1	1
Physical Resistance/Sticking	1	1
Thermal Decomposition of Device	1	1
Device Damaged by Another Device	1	1
Data Problem	1	1
Volume Accuracy Problem	1	1
No Display/Image	1	1
Device Emits Odor	1	1
Low Readings	1	1
Protective Measures Problem	1	1
Melted	1	1
Nonstandard Device	1	1
Device Ingredient or Reagent Problem	1	1
Electrical /Electronic Property Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1683	1684
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