MAUDE MDR 2836626

MDR report key
2836626
Report number
2050012-2012-01844
Event key
0
Event type
3
Date of event
2012-10-23
Date received
2012-11-16
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? IMMUNOCHEMISTRY SYSTEMNEPHELOMETER, FOR CLINICAL USEBECKMAN COULTER, INC.JQX47000N/AY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-11-160

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTED THE REAGENT PROBE WASH STATION OVERFLOWED AND DID NOT DRAINING ON THE IMMAGE IMMUNOCHEMISTRY SYSTEM. THE LEAK WAS CONTAINED TO THE TOP OF THE INSTRUMENT. THE CUSTOMER INSPECTED THE WASH CUP FOR OBSTRUCTIONS; NO OBSTRUCTIONS WERE FOUND. THE CUSTOMER WORE PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, EYE PROTECTION, AND LAB COAT AT THE TIME OF THE INCIDENT. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT OR RESULTS ARE ATTRIBUTED OR ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT REVIEW THE MSDS; HOWEVER, THE FACILITY HAS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE.

N

Patient 1

ON (B)(4) 2012, A FIELD SERVICE ENGINEER (FSE) WAS ON SITE TO INVESTIGATE THE INCIDENT. THE FSE REMOVED THE WASH STATION AND CLEANED THE WASH CUP. THE FSE THEN INSPECTED THE TUBING AND NO OBSTRUCTION WAS NOTED. THE FSE REPLACED THE IN-LINER FILTER WHICH RESOLVED THE LEAK. THE FAILURE MODE OF THE EVENT WAS A WEAK IN-LINE FILTER FAILURE (B)(4).