MAUDE MDR 9853536

MDR report key: 9853536
Report number: 1950204-2020-00080
Event key: 0
Event type: 3
Date received: 2020-03-19
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 100
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: MRS. DANIELLE COOPER
Address: 595 ANGLUM ROAD HAZELWOOD MO 63042 US
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	VITEK? 2 AST-P652 TEST KIT	VITEK? 2 AST-P652 TEST KIT	BIOMERIEUX, INC.	LON		421857	8021232403				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2020-03-19	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
07350136800344	ASTar BC G- Kit software	Q-Linea AB	LON	2026-05-12
30382904490851	NMIC-315	BECTON, DICKINSON AND COMPANY	LON	2026-01-29
00382904490850	NMIC-315	BECTON, DICKINSON AND COMPANY	LON	2026-01-29
15099590799717	MicroScan	Beckman Coulter, Inc.	LON	2025-12-17
15099590799724	MicroScan	Beckman Coulter, Inc.	LON	2025-12-17
15099590799755	MicroScan	Beckman Coulter, Inc.	LON	2025-12-17
15099590799762	MicroScan	Beckman Coulter, Inc.	LON	2025-12-17
03573026647780	VITEK® 2 AST-N816	BIOMERIEUX , INC.	LON	2025-11-21
00860012092109	LifeScale AST	Affinity Biosensors, LLC	LON	2025-10-14
00860012092116	LSGN	Affinity Biosensors, LLC	LON	2025-10-14
00860012092123	LifeScale Sensor	Affinity Biosensors, LLC	LON	2025-10-14
03573026615499	VITEK® COMPACT PRO	BIOMERIEUX , INC.	LON	2025-05-15
03573026618285	VITEK	BIOMERIEUX , INC.	LON	2025-05-15
30382904490820	NMIC-312	BECTON, DICKINSON AND COMPANY	LON	2025-03-20
30382904490837	NMIC/ID-313	BECTON, DICKINSON AND COMPANY	LON	2025-03-20
00382904449575	BDXpert™ System	BECTON, DICKINSON AND COMPANY	LON	2025-03-20
00382904490829	NMIC-312	BECTON, DICKINSON AND COMPANY	LON	2025-03-20
00382904490836	NMIC/ID-313	BECTON, DICKINSON AND COMPANY	LON	2025-03-20
00850031114029	Selux AST Gram Negative Panel	Selux Diagnostics, Inc.	LON	2024-12-20
00850031114142	Selux Seaparator Reagent Kit	Selux Diagnostics, Inc.	LON	2024-12-20
00195893563760	Selux AST System	Selux Diagnostics, Inc.	LON	2024-12-20
00850031114005	Bulk Analyzer Reagent Pack	Selux Diagnostics, Inc.	LON	2024-12-20
10850031114026	Selux AST Gram Negative Panel	Selux Diagnostics, Inc.	LON	2024-12-20
00850031114036	AST Inoculator	Selux Diagnostics, Inc.	LON	2024-12-20
00850031114043	AST Analyzer	Selux Diagnostics, Inc.	LON	2024-12-20
00850031114067	PBC Separator with Selux AST System	Selux Diagnostics, Inc.	LON	2024-12-20
10850031114149	Selux Seaparator Reagent Kit	Selux Diagnostics, Inc.	LON	2024-12-20
00850031114135	Selux AST Gram Positive Panels	Selux Diagnostics, Inc.	LON	2024-12-17
03573026641320	VITEK® 2 AST-N815	BIOMERIEUX , INC.	LON	2024-11-13
03573026641337	VITEK® 2 AST-N815	BIOMERIEUX , INC.	LON	2024-11-13

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K260282	LON	VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance	bioMerieux, Inc.	2026-04-15
510(k)	K260281	LON	VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)	BIOMERIEUX	2026-03-26
510(k)	K251579	LON	VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)	bioMerieux, Inc.	2025-08-21
510(k)	K251713	LON	BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)	Becton, Dickinson and Company	2025-08-08
510(k)	K250447	LON	BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)	Becton, Dickinson and Company	2025-05-19
PMA	P870049S032	LON	MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS	Dade Intl., Inc.	2001-11-30
PMA	P870049S031	LON	MICROSCAN RAPID FLUOROGENIC PANELS	Dade Intl., Inc.	2001-11-09
PMA	P870049S030	LON	MICROSCAN(R) RAPID FLUOROGENIC PANELS	Dade Intl., Inc.	2000-06-05
PMA	P870049S029	LON	MICROSCAN RAPID FLUOROGENIC PANELS	Dade Intl., Inc.	1999-06-24
PMA	P870049S028	LON	MICROSCAN RAPID FLUOROGENIC PANELS	Dade Intl., Inc.	1999-01-25

MAUDE MDR 9853536

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#