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	1157	1185
Program or Algorithm Execution Problem	316	316
Fluid/Blood Leak	232	233
Incorrect, Inadequate or Imprecise Result or Readings	226	236
Device Dislodged or Dislocated	194	194
False Negative Result	138	138
Unable to Obtain Readings	76	76
Structural Problem	56	56
Mechanical Problem	55	55
No Apparent Adverse Event	22	22
Smoking	20	20
Human-Device Interface Problem	11	11
Sparking	7	7
Break	6	6
Defective Device	6	6
Temperature Problem	5	5
Detachment of Device or Device Component	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Leak/Splash	5	5
Patient Data Problem	4	4
Fire	4	4
Device Fell	3	3
Failure to Obtain Sample	3	3
Unintended Electrical Shock	3	3
Nonstandard Device	3	3
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
Defective Component	1	1
Insufficient Information	1	1
Therapeutic or Diagnostic Output Failure	1	1
Patient Device Interaction Problem	1	1
Ejection Problem	1	1
Device Markings/Labelling Problem	1	1
Flare or Flash	1	1
Thermal Decomposition of Device	1	1
Crack	1	1
Device Damaged by Another Device	1	1
Missing Test Results	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
Unexpected Shutdown	1	1
Power Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2486	2525
No Consequences Or Impact To Patient	25	25
Insufficient Information	8	8
Abrasion	6	6
Skin Tears	4	4
Electric Shock	2	2
No Patient Involvement	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Pallor	1	1
Limb Fracture	1	1
Bruise/Contusion	1	1