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	1334	1334
False Positive Result	186	186
Device Markings/Labelling Problem	33	33
Mechanical Problem	21	21
Computer Software Problem	19	19
Contamination	18	18
False Negative Result	14	14
Low Test Results	13	13
Missing Test Results	11	11
Improper or Incorrect Procedure or Method	10	10
Contamination of Device Ingredient or Reagent	10	10
Use of Device Problem	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
Microbial Contamination of Device	3	3
Loss of Data	3	3
Leak/Splash	3	3
Expiration Date Error	2	2
Patient Data Problem	2	2
Insufficient Information	2	2
Application Program 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
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
Incomplete or Missing Packaging	1	1
Illegible Information	1	1
Missing Information	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Inaccurate Information	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	1156	1156
No Known Impact Or Consequence To Patient	409	409
No Consequences Or Impact To Patient	111	111
No Patient Involvement	33	33
Insufficient Information	17	17
Misdiagnosis	15	15
Drug Resistant Bacterial Infection	2	2
Unspecified Infection	1	1
Death	1	1
Sepsis	1	1
Test Result	1	1
Chemical Exposure	1	1
Localized Skin Lesion	1	1
Bacterial Infection	1	1