TPLC - Total Product Life Cycle

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Device	system, test, automated, antimicrobial susceptibility, short incubation
Regulation Description	Fully automated short-term incubation cycle antimicrobial susceptibility system.
Product Code	LON
Regulation Number	866.1645
Device Class	2

Premarket Reviews
Manufacturer	Decision
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	4
BIOMERIEUX
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX SA, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	22
BIOMÉRIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	1
COPAN WASP SRL
	SUBSTANTIALLY EQUIVALENT	2
SELUX DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	1897	1903
Incorrect Measurement	159	159
Device Contamination with Chemical or Other Material	103	103
False Positive Result	62	62
Contamination	41	41
Device Markings/Labelling Problem	37	37
Mechanical Problem	21	21
False Negative Result	19	19
Low Test Results	14	14
Therapeutic or Diagnostic Output Failure	13	13
Contamination of Device Ingredient or Reagent	10	10
Unable to Obtain Readings	8	8
Missing Test Results	8	8
Appropriate Device Problem Term/Code Not Available	6	6
Output Problem	4	4
Leak/Splash	3	3
Microbial Contamination of Device	3	3
Data Problem	3	3
Computer Software Problem	3	3
Loss of Data	3	3
Device Ingredient or Reagent Problem	2	2
Incomplete or Missing Packaging	2	2
Application Program Problem	2	2
Expiration Date Error	2	2
Patient Data Problem	2	2
High Test Results	2	2
Nonstandard Device	2	2
No Device Output	2	2
Cross Reactivity	1	1
Program or Algorithm Execution Failure	1	1
Unsealed Device Packaging	1	1
High Readings	1	1
Failure to Back-Up	1	1
Decreased Sensitivity	1	1
No Apparent Adverse Event	1	1
Illegible Information	1	1
Missing Information	1	1
Inaccurate Information	1	1
Electrical /Electronic Property Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2378	2384
No Consequences Or Impact To Patient	24	24
Insufficient Information	18	18
No Known Impact Or Consequence To Patient	9	9
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	6	6
No Patient Involvement	3	3
Drug Resistant Bacterial Infection	2	2
Sepsis	1	1
Localized Skin Lesion	1	1
Laceration(s)	1	1
Bacterial Infection	1	1