TPLC - Total Product Life Cycle

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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 & COMPANY
	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	11
BIOMÉRIEUX, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	18

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings	1028	1028
Incorrect Or Inadequate Test Results	193	193
False Positive Result	181	181
Mechanical Problem	21	21
Computer Software Problem	19	19
False Negative Result	14	14
Missing Test Results	13	13
Improper or Incorrect Procedure or Method	10	10
Use of Device Problem	10	10
Contamination	9	9
Contamination of Device Ingredient or Reagent	9	9
Incorrect Measurement	8	8
Output Problem	7	7
Communication or Transmission Problem	5	5
Failure to Back-Up	3	3
Smoking	3	3
Electrical /Electronic Property Problem	3	3
Unable to Obtain Readings	3	3
Device Damaged Prior to Use	3	3
Data Back-Up Problem	3	3
Device Markings/Labelling Problem	3	3
No Device Output	2	2
Insufficient Information	2	2
Loss of Data	2	2
Patient Data Problem	2	2
Expiration Date Error	2	2
Sparking	1	1
Fire	1	1
Unsealed Device Packaging	1	1
Device Operational Issue	1	1
Program or Algorithm Execution Failure	1	1
Inaccurate Information	1	1
Data Problem	1	1
Leak/Splash	1	1
Product Quality Problem	1	1
Low Test Results	1	1
Failure to Obtain Sample	1	1
Packaging Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
High Readings	1	1
Device Displays Incorrect Message	1	1
Cross Reactivity	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	731	731
No Consequences Or Impact To Patient	380	380
No Clinical Signs, Symptoms or Conditions	272	272
No Patient Involvement	127	127
Misdiagnosis	37	37
Insufficient Information	2	2
Test Result	1	1
No Information	1	1
Drug Resistant Bacterial Infection	1	1
Death	1	1
Unspecified Infection	1	1
Needle Stick/Puncture	1	1
Premature Labor	1	1
Chemical Exposure	1	1