TPLC - Total Product Life Cycle

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Device	clinical sample concentrator
Regulation Description	Clinical sample concentrator.
Product Code	JJH
Regulation Number	862.2310
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Suction Failure	21	21
False Positive Result	16	17
Unintended Movement	10	10
Low Test Results	8	8
Failure to Align	7	7
Low Sensing Threshold	6	6
Leak/Splash	5	5
Contamination of Device Ingredient or Reagent	5	5
Fluid/Blood Leak	5	5
Failure to Transmit Record	4	4
Contamination	4	4
Pressure Problem	3	3
Defective Component	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Improper or Incorrect Procedure or Method	3	3
False Negative Result	2	2
Mechanical Problem	2	2
Short Fill	2	2
Use of Device Problem	2	2
Nonstandard Device	2	2
Human-Device Interface Problem	2	2
Electrical /Electronic Property Problem	2	2
Failure to Read Input Signal	1	1
Failure to Eject	1	1
Separation Failure	1	1
Microbial Contamination of Device	1	1
Contamination /Decontamination Problem	1	1
Ejection Problem	1	1
Degraded	1	1
Unable to Obtain Readings	1	1
Positioning Failure	1	1
Failure to Back-Up	1	1
Mechanics Altered	1	1
Missing Test Results	1	1
Device Dislodged or Dislocated	1	1
High Sensing Threshold	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	117	118
Insufficient Information	4	4
Abrasion	2	2
Chemical Exposure	1	1
Swelling/ Edema	1	1