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	2
BIOMERIEUX SA, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC
	SUBSTANTIALLY EQUIVALENT	15
BIOMÉRIEUX, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	15
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	1191	1191
False Positive Result	183	183
Mechanical Problem	21	21
Computer Software Problem	19	19
Contamination	18	18
False Negative Result	14	14
Low Test Results	13	13
Device Markings/Labelling Problem	13	13
Missing Test Results	11	11
Contamination of Device Ingredient or Reagent	10	10
Use of Device Problem	10	10
Improper or Incorrect Procedure or Method	10	10
Incorrect Measurement	9	9
Output Problem	7	7
Communication or Transmission Problem	5	5
Device Contamination with Chemical or Other Material	4	4
Loss of Data	3	3
Leak/Splash	3	3
Microbial Contamination of Device	3	3
No Device Output	2	2
Electrical /Electronic Property Problem	2	2
Device Ingredient or Reagent Problem	2	2
Patient Data Problem	2	2
Insufficient Information	2	2
Expiration Date Error	2	2
Unable to Obtain Readings	2	2
Application Program Problem	2	2
Decreased Sensitivity	1	1
Sparking	1	1
High Readings	1	1
Smoking	1	1
Data Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Failure to Back-Up	1	1
Cross Reactivity	1	1
Unsealed Device Packaging	1	1
Product Quality Problem	1	1
Incomplete or Missing Packaging	1	1
High Test Results	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Program or Algorithm Execution Failure	1	1
Illegible Information	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	979	979
No Known Impact Or Consequence To Patient	409	409
No Consequences Or Impact To Patient	111	111
No Patient Involvement	33	33
Misdiagnosis	15	15
Insufficient Information	15	15
Drug Resistant Bacterial Infection	2	2
Test Result	1	1
Localized Skin Lesion	1	1
Chemical Exposure	1	1
Bacterial Infection	1	1
Death	1	1
Unspecified Infection	1	1
Sepsis	1	1