FDA.reportPublic FDA data

MAUDE MDR 2361542

MDR report key
2361542
Report number
2050012-2011-08219
Event key
0
Event type
3
Date of event
2011-10-26
Date received
2011-12-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. DUNG NGUYEN
Address
250 S. KRAEMER BLVD. BREA CA 92821 US
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT;SYSTEM, TEST, C-REACTIVE PROTEINBECKMAN COULTER, INC.DCN969739M101480Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-12-070

Event Narratives#

D

Patient 1

CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY RECEIVED THE C-REACTIVE PROTEIN REAGENT BOTTLES WITH THE INSIDE PACKAGING LEAKING. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

N

Patient 1

C-REACTIVE PROTEIN REAGENT CONTAINS MATERIALS OF HUMAN ORIGIN AND SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS. (B)(4).