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
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	4
BIOMERIEUX SA, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	25
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	1648	1654
False Positive Result	159	159
Device Contamination with Chemical or Other Material	103	103
Contamination	41	41
Incorrect Measurement	37	37
Device Markings/Labelling Problem	34	34
False Negative Result	21	21
Mechanical Problem	21	21
Low Test Results	13	13
Contamination of Device Ingredient or Reagent	10	10
Missing Test Results	10	10
Unable to Obtain Readings	8	8
Output Problem	7	7
Computer Software Problem	4	4
Leak/Splash	3	3
Loss of Data	3	3
Microbial Contamination of Device	3	3
No Device Output	2	2
Electrical /Electronic Property Problem	2	2
High Test Results	2	2
Patient Data Problem	2	2
Expiration Date Error	2	2
Insufficient Information	2	2
Application Program Problem	2	2
Communication or Transmission Problem	2	2
Device Ingredient or Reagent Problem	2	2
High Readings	1	1
Failure to Back-Up	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Smoking	1	1
Data Problem	1	1
Unsealed Device Packaging	1	1
Product Quality Problem	1	1
Decreased Sensitivity	1	1
Program or Algorithm Execution Failure	1	1
No Apparent Adverse Event	1	1
Illegible Information	1	1
Missing Information	1	1
Nonstandard Device	1	1
Inaccurate Information	1	1
Incomplete or Missing Packaging	1	1
Sparking	1	1
Cross Reactivity	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1905	1911
No Known Impact Or Consequence To Patient	194	194
No Consequences Or Impact To Patient	40	40
No Patient Involvement	18	18
Insufficient Information	17	17
Drug Resistant Bacterial Infection	2	2
Unspecified Infection	1	1
Death	1	1
Sepsis	1	1
Chemical Exposure	1	1
Localized Skin Lesion	1	1
Bacterial Infection	1	1