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	955	983
Program or Algorithm Execution Problem	316	316
Incorrect, Inadequate or Imprecise Result or Readings	309	319
Fluid/Blood Leak	231	232
Device Dislodged or Dislocated	194	194
False Negative Result	108	108
Unable to Obtain Readings	71	71
Mechanical Problem	54	54
Structural Problem	50	50
No Apparent Adverse Event	22	22
Smoking	22	22
Human-Device Interface Problem	11	11
Sparking	7	7
Temperature Problem	6	6
Detachment of Device or Device Component	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Patient Data Problem	4	4
Fire	4	4
Leak/Splash	4	4
Device Fell	3	3
Failure to Obtain Sample	3	3
Unintended Electrical Shock	3	3
Nonstandard Device	3	3
Therapeutic or Diagnostic Output Failure	2	2
Non Reproducible Results	2	2
Use of Device Problem	2	2
Output Problem	2	2
Overheating of Device	2	2
Difficult to Open or Close	2	2
Improper or Incorrect Procedure or Method	2	2
Insufficient Information	1	1
Defective Component	1	1
Unintended Movement	1	1
Ejection Problem	1	1
Device Markings/Labelling Problem	1	1
Failure to Power Up	1	1
Flare or Flash	1	1
Crack	1	1
Thermal Decomposition of Device	1	1
Device Damaged by Another Device	1	1
Physical Resistance/Sticking	1	1
High Test Results	1	1
Data Problem	1	1
Device Emits Odor	1	1
Power Conditioning Problem	1	1
Low Readings	1	1
Volume Accuracy Problem	1	1
No Display/Image	1	1
Melted	1	1
Device Ingredient or Reagent Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2238	2277
No Consequences Or Impact To Patient	108	108
No Known Impact Or Consequence To Patient	18	18
No Patient Involvement	17	17
Insufficient Information	10	10
Abrasion	6	6
Skin Tears	4	4
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
Bruise/Contusion	1	1