FDA.reportPublic FDA data

MAUDE MDR 2855139

MDR report key
2855139
Report number
2050012-2012-01896
Event key
0
Event type
3
Date of event
2012-11-07
Date received
2012-12-03
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
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
12012-12-030

Event Narratives#

D

Patient 1

A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM LEAKED A CLEAR AND ODORLESS FLUID FROM THE SAMPLE DRAIN UNDER THE PROBE. THE FLUID DRIPPED ONTO THE FLOOR. THE CUSTOMER WAS WEARING GLOVES AND EYE PROTECTION WHEN THE LEAK WAS DISCOVERED. THERE WAS NO REPORT OF INJURY OR EXPOSURE, AND MEDICAL ATTENTION WAS NOT SOUGHT. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EMERGENCY CHEMICAL SPILL PLAN IN PLACE. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. BEC FIELD SERVICE ENGINEER (FSE) OBSERVED A SAMPLE PROBE WASH STATION OVERFLOW. THE FSE REPLACED BOTH WASH STATION WASTE FILTERS AND THE CUVETTE WASH STATION WASTE FILTER. SERVICE ACTIVITY PERFORMED WAS VERIFIED PER ESTABLISHED PROCEDURES, AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

N

Patient 1

(B)(4).