TPLC - Total Product Life Cycle

show TPLC since

Device	system, test, automated, antimicrobial susceptibility, short incubation
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	1
BIOMERIEUX SA, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC
	SUBSTANTIALLY EQUIVALENT	13
BIOMÉRIEUX, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	10
COPAN WASP S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
SELUX DIAGNOSTICS, INC
	SUBSTANTIALLY EQUIVALENT	1
SELUX DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	1163	1163
False Positive Result	148	148
Device Markings/Labelling Problem	34	34
Mechanical Problem	21	21
Contamination	18	18
Low Test Results	13	13
False Negative Result	11	11
Contamination of Device Ingredient or Reagent	10	10
Missing Test Results	10	10
Incorrect Measurement	9	9
Output Problem	7	7
Device Contamination with Chemical or Other Material	4	4
Computer Software Problem	4	4
Microbial Contamination of Device	3	3
Loss of Data	3	3
Leak/Splash	3	3
Application Program Problem	2	2
Insufficient Information	2	2
Expiration Date Error	2	2
Communication or Transmission Problem	2	2
Unable to Obtain Readings	2	2
Device Ingredient or Reagent Problem	2	2
Electrical /Electronic Property Problem	2	2
No Device Output	2	2
Program or Algorithm Execution Failure	1	1
Unsealed Device Packaging	1	1
Smoking	1	1
Patient Data Problem	1	1
Incomplete or Missing Packaging	1	1
High Readings	1	1
Failure to Back-Up	1	1
Adverse Event Without Identified Device or Use Problem	1	1
High Test Results	1	1
Data Problem	1	1
Product Quality Problem	1	1
Decreased Sensitivity	1	1
Sparking	1	1
Illegible Information	1	1
Missing Information	1	1
Inaccurate Information	1	1
Cross Reactivity	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1239	1239
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