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
BECTON, DICKINSON, AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BECTON,DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC
	SUBSTANTIALLY EQUIVALENT	12
BIOMÉRIEUX, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	13
COPAN WASP S.R.L.
	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	1050	1050
False Positive Result	182	182
Incorrect Or Inadequate Test Results	66	66
Mechanical Problem	21	21
Computer Software Problem	19	19
Contamination	15	15
False Negative Result	12	12
Low Test Results	11	11
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	8	8
Output Problem	7	7
Communication or Transmission Problem	5	5
Device Markings/Labelling Problem	4	4
Unable to Obtain Readings	3	3
Data Back-Up Problem	3	3
Failure to Back-Up	3	3
Electrical /Electronic Property Problem	2	2
No Device Output	2	2
Loss of Data	2	2
Application Program Problem	2	2
Expiration Date Error	2	2
Insufficient Information	2	2
Data Problem	1	1
Patient Data Problem	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Program or Algorithm Execution Failure	1	1
Illegible Information	1	1
Inaccurate Information	1	1
Decreased Sensitivity	1	1
Device Displays Incorrect Message	1	1
Sparking	1	1
High Readings	1	1
High Test Results	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Device Ingredient or Reagent Problem	1	1
Unsealed Device Packaging	1	1
Product Quality Problem	1	1
Smoking	1	1
Cross Reactivity	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	645	645
No Clinical Signs, Symptoms or Conditions	374	374
No Consequences Or Impact To Patient	319	319
No Patient Involvement	95	95
Misdiagnosis	19	19
Insufficient Information	9	9
Drug Resistant Bacterial Infection	2	2
Test Result	1	1
Chemical Exposure	1	1
Death	1	1
Unspecified Infection	1	1
Sepsis	1	1