MAUDE MDR 2544967

MDR report key: 2544967
Report number: 2027969-2012-00535
Event key: 0
Event type: 3
Date of event: 2012-03-26
Date received: 2012-04-18
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: CARMEN BERGELIN, MANAGER
Address: 9975 SUMMERS RIDGE RD SAN DIEGO CA 92121 US
Phone: 858-858-8588
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	TRIAGE D-DIMER TEST	CARDIAC MARKER TEST	ALERE SAN DIEGO, INC.	GJA	98100		W50551B				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2012-04-18	0

Event Narratives#

D

Patient 1

CUSTOMER ALLEGES FALSE NEGATIVE D-DIMER RESULTS WITH 3 SAMPLES WHILE RUNNING A PLASMA TO WHOLE BLOOD CORRELATION STUDY: SAMPLE NUMBER: (B)(6), PLASMA: 599, WHOLE BLOOD: 296. SAMPLE NUMBER: (B)(6), PLASMA: 444, WHOLE BLOOD: 252. SAMPLE NUMBER: (B)(6), PLASMA: 481, WHOLE BLOOD: 254. CUSTOMER USES A CUTOFF OF 400 TO DETERMINE POSITIVE D-DIMER RESULTS: THIS CORRELATION STUDY WAS RUN USING 2 TRIAGE METERS. RESULTS FROM THE OTHER METER (NUMBER 66704) HAVE BEEN REPORTED ON MDR NUMBER 2027969-2012-00534.

N

Patient 1

INVESTIGATION PENDING.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00630414639635	Test Thrombin Reagent	Siemens Healthcare Diagnostics Products GmbH	GJA	2024-03-25
10859394006054	T-tek	R 2 DIAGNOSTICS, INC.	GJA	2016-11-15
00842768012716	Test Thrombin Reagent	Siemens Healthcare Diagnostics Products GmbH	GJA	2016-09-24
00842768013102	BC Thrombin Reagent	Siemens Healthcare Diagnostics Products GmbH	GJA	2016-09-24
08426950058366	HemosIL Thrombin Time	INSTRUMENTATION LABORATORY COMPANY	GJA	2016-09-23
13607450006114	STA® - Thrombin 2	DIAGNOSTICA STAGO	GJA	2016-09-15
13607450006695	STA® - Thrombin 10	DIAGNOSTICA STAGO	GJA	2016-09-15
M52553770	Thrombin Clotting Time Reagent	HELENA LABORATORIES CORPORATION	GJA	2016-09-07

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K050817	GJA	T-TEK	R2 Diagnostics, Inc.	2005-12-12
510(k)	K982209	GJA	ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589	Sigma Diagnostics, Inc.	1998-10-15
510(k)	K970645	GJA	BC THROMBIN REAGENT	Behring Diagnostics, Inc.	1997-05-19
510(k)	K925493	GJA	BIOMERIEUX HEMOLAB THROMBICALCI-TEST	Biomerieux Vitek, Inc.	1994-04-21
510(k)	K930157	GJA	TEST THROMBIN	Behring Diagnostics, Inc.	1993-05-14

MAUDE MDR 2544967

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

N

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Related PMN/PMA Records By Product Code#