TPLC - Total Product Life Cycle

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Device	system, test, automated, antimicrobial susceptibility, short incubation
Regulation Description	Fully automated short-term incubation cycle antimicrobial susceptibility system.
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	10
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	16

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings	976	976
Incorrect Or Inadequate Test Results	193	193
False Positive Result	180	180
Mechanical Problem	21	21
Computer Software Problem	19	19
False Negative Result	14	14
Missing Test Results	11	11
Use of Device Problem	10	10
Improper or Incorrect Procedure or Method	10	10
Contamination of Device Ingredient or Reagent	8	8
Incorrect Measurement	7	7
Output Problem	6	6
Communication or Transmission Problem	5	5
Unable to Obtain Readings	3	3
Data Back-Up Problem	3	3
Device Markings/Labelling Problem	3	3
Failure to Back-Up	3	3
Electrical /Electronic Property Problem	3	3
Device Damaged Prior to Use	3	3
Smoking	3	3
No Device Output	2	2
Contamination	2	2
Loss of Data	2	2
Expiration Date Error	2	2
Insufficient Information	2	2
Patient Data Problem	2	2
Data Problem	1	1
Failure to Obtain Sample	1	1
Device Displays Incorrect Message	1	1
Sparking	1	1
Device Operational Issue	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Packaging Problem	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Program or Algorithm Execution Failure	1	1
Inaccurate Information	1	1
Cross Reactivity	1	1
Fire	1	1
Leak/Splash	1	1
Unsealed Device Packaging	1	1
Product Quality Problem	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	206	206
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