TPLC - Total Product Life Cycle

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Device	real time nucleic acid amplification system
Regulation Description	Instrumentation for clinical multiplex test systems.
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	742	742
Program or Algorithm Execution Problem	316	316
Incorrect, Inadequate or Imprecise Result or Readings	301	301
Device Dislodged or Dislocated	194	194
Fluid/Blood Leak	185	185
False Negative Result	60	60
Unable to Obtain Readings	56	57
Mechanical Problem	53	53
Structural Problem	39	39
Smoking	21	21
No Apparent Adverse Event	16	16
Human-Device Interface Problem	9	9
Sparking	7	7
Temperature Problem	6	6
Detachment of Device or Device Component	5	5
Leak/Splash	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Patient Data Problem	4	4
Failure to Obtain Sample	3	3
Unintended Electrical Shock	3	3
Fire	3	3
Device Fell	2	2
Non Reproducible Results	2	2
Output Problem	2	2
Overheating of Device	2	2
Difficult to Open or Close	2	2
Insufficient Information	1	1
Unintended Movement	1	1
Defective Component	1	1
Therapeutic or Diagnostic Output Failure	1	1
Ejection Problem	1	1
Device Markings/Labelling Problem	1	1
Crack	1	1
Failure to Power Up	1	1
Use of Device Problem	1	1
Thermal Decomposition of Device	1	1
Device Damaged by Another Device	1	1
Data Problem	1	1
Physical Resistance/Sticking	1	1
Volume Accuracy Problem	1	1
Device Emits Odor	1	1
Low Readings	1	1
No Display/Image	1	1
Melted	1	1
Nonstandard Device	1	1
Electrical /Electronic Property Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Jam	1	1
Device Ingredient or Reagent Problem	1	1
Fumes or Vapors	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1884	1885
No Consequences Or Impact To Patient	108	108
No Known Impact Or Consequence To Patient	18	18
No Patient Involvement	17	17
Insufficient Information	9	9
Abrasion	6	6
Electric Shock	2	2
Test Result	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Information	1	1
Head Injury	1	1
Pallor	1	1
Limb Fracture	1	1
Skin Tears	1	1
Bruise/Contusion	1	1