MAUDE MDR 9344978

MDR report key: 9344978
Report number: 1219029-2019-00066
Event key: 0
Event type: 3
Date of event: 2019-11-04
Date received: 2019-11-19
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: MS MARIYA CESNULEVICIUS
Address: 200 PROSPECT ST. WALTHAM MA 02454 US
Phone: 781-781-7816
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	STAT PROFILE PRIME PLUS ANALYZER SYSTEM	BLOOD GAS ANALYZER	NOVA BIOMEDICAL CORP	CGL	57400						Y	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-19	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
10054749005519	i-STAT	ABBOTT POINT OF CARE INC.	CGL	2020-05-01
05700699441362	S8377 REF 944-136 *6 Cleaning solution Met II Solution	Radiometer Medical ApS	CGL	2018-09-21
05700699058027	Disposable Waste Container D513 REF 905-802	Radiometer Medical ApS	CGL	2018-09-21
05700699439062	S5362 REF 943-906	Radiometer Medical ApS	CGL	2018-09-21
05700699441263	Cleaning Solution with additive S8375 REF 944-126	Radiometer Medical ApS	CGL	2018-09-21
05700699441300	Rinse Solution S4980 REF 944-130	Radiometer Medical ApS	CGL	2018-09-21
05700699441553	Rinse Solution II S4987 REF 944-155 600mL	Radiometer Medical ApS	CGL	2018-09-21
00385480183420	NOVA	NOVA BIOMEDICAL CORPORATION	CGL	2017-04-24
10385480433706	STATSENSOR	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
10385480528006	STATSENSOR	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480282413	NOVA	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480359429	STAT PROFILE	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480374132	STAT PROFILE	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480375559	STAT PROFILE	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480375627	STAT PROFILE	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480420136	STAT PROFILE	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480420143	STAT PROFILE	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480420174	STAT PROFILE	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480420181	STAT PROFILE	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480422253	StatSensor/StatStrip	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480438063	StatSensor/StatStrip	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480440523	StatSensor	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480453356	StatSensor	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480485623	STAT PROFILE	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480486293	StatSensor/StatStrip	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480486309	StatSensor/StatStrip	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480506687	StatSensor	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480517560	StatSensor/StatStrip	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480519946	StatSensor/StatStrip	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20
00385480519953	StatSensor/StatStrip	NOVA BIOMEDICAL CORPORATION	CGL	2016-09-20

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K171059	CGL	Nova StatSensor Creatinine Hospital Meter System	Nova Biomedical Corporation	2017-05-26
510(k)	K113726	CGL	EPOC CHLORIDE TEST AND EPOC CREATININE TEST	Epocal, Inc.	2012-10-05
510(k)	K070068	CGL	NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS	Nova Biomedical Corp.	2007-05-07
510(k)	K051968	CGL	ABL8X7 FLEX	Radiometer Medical Aps	2006-10-16
510(k)	K991727	CGL	STAT PROFILE M7 ANALYZER	Nova Biomedical Corp.	1999-07-16

MAUDE MDR 9344978

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#