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	1763	1769
Device Contamination with Chemical or Other Material	103	103
Incorrect Measurement	59	59
False Positive Result	57	57
Contamination	41	41
Device Markings/Labelling Problem	34	34
Mechanical Problem	21	21
False Negative Result	17	17
Low Test Results	13	13
Contamination of Device Ingredient or Reagent	10	10
Unable to Obtain Readings	8	8
Missing Test Results	8	8
Appropriate Term/Code Not Available	6	6
Output Problem	4	4
Computer Software Problem	4	4
Leak/Splash	3	3
Microbial Contamination of Device	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
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
Data Problem	1	1
Decreased Sensitivity	1	1
No Apparent Adverse Event	1	1
Illegible Information	1	1
Missing Information	1	1
Nonstandard Device	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	2138	2144
No Consequences Or Impact To Patient	24	24
Insufficient Information	17	17
No Known Impact Or Consequence To Patient	9	9
Appropriate Clinical Signs, Symptoms, 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