MAUDE MDR 590926

MDR report key: 590926
Report number: 1122376-2004-00001
Event key: 0
Event type: 3
Date received: 2004-06-06
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: DONNA SOWERS
Address: 1201 CLOPPER ROAD GAITHERSBURG MD 20878 US
Phone: 301-301-3019
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	HYBRID CAPTURE SYSTEM CMV DNA TEST VERSION 2.0	IN-VITRO DIAGNOSTIC	DIGENE CORPORATION	LJO	NA	4403-2003	6234		K974901	N	Y	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2004-06-06	0

Event Narratives#

D

Patient 1

CLINICAL LABORATORY REPORTED AN ESSAY VALIDATION FAILURE. THE REPORT INDICATED THAT ALL ASSAY VALUES, INCLUDING POSITIVE CONTROLS AND TARGETS, WERE VERY LOW. RETURNED PRODUCT WAS EVALUATED AND IT WAS DETERMINED THAT SOME OF THE TUBES WERE NOT COATED WITH ANTIBODY.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00817273020013	Diamedix	DIAMEDIX CORPORATION	LJO	2016-09-20
00817273020020	Diamedix	DIAMEDIX CORPORATION	LJO	2016-09-20
00817273020167	Diamedix	DIAMEDIX CORPORATION	LJO	2016-09-20
10888234001157	Capture-CMV	IMMUCOR, INC.	LJO	2016-04-14
10888234001232	Capture-CMV Indicator Red Cells	IMMUCOR, INC.	LJO	2016-04-14
10888234001249	Capture-CMV Control set	IMMUCOR, INC.	LJO	2016-04-14
10888234002154	Capture-CMV	IMMUCOR, INC.	LJO	2016-04-14

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K203612	LJO	Capture-CMV	Immucor, Inc.	2021-03-22
510(k)	K183571	LJO	Capture-CMV	Immucor, Inc.	2019-02-04
510(k)	K001767	LJO	DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM	Diamedix Corp.	2000-08-07
510(k)	K974901	LJO	HYBRID CAPTURE SYSTEM CMV DNA ASSAY	Digene Corp.	1998-09-29
510(k)	K974456	LJO	CMVGEN	Instrumentation Laboratory CO	1998-05-01

MAUDE MDR 590926

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

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