FDA.reportPublic FDA data

MAUDE MDR 2671837

MDR report key
2671837
Report number
2050012-2012-01630
Event key
0
Event type
3
Date of event
2012-07-09
Date received
2012-07-26
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
1IMMAGE? 800 IMMUNOCHEMISTRY SYSTEMNEPHELOMETER, FOR CLINICAL USEBECKMAN COULTER, INC.JQXIMMAGE 800A15445NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-07-260

Event Narratives#

D

Patient 1

A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT A FLUID LEAK UNDER IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE CUSTOMER DISCOVERED A PUDDLE OF FLUID UNDERNEATH THE INSTRUMENT WHILE RUNNING QC. QC RESULTS WERE ACCEPTABLE, BUT THE CUSTOMER STOPPED RUNNING THE INSTRUMENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THE OPERATOR WAS WEARING GLOVES AND LAB COAT, AND MADE NO DIRECT SKIN CONTACT WHILE CLEANING UP THE PUDDLE. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION, AND NO INJURY WAS REPORTED. A FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND IDENTIFIED A LOOSE FITTING ON THE SYRINGE MANIFOLD. THE FSE SECURED THE FITTING TO RESOLVE THE ISSUE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES.

N

Patient 1

(B)(4).