IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM
Received May 16, 2012 · Event occurred Apr 17, 2012
Report 2050012-2012-01072 · MDR key 2575541
Device
Generic name
Nephelometer, For Clinical Use
Manufacturer
Beckman Coulter, Inc.Model number
IMMAGE 800Catalog number
A15445
Lot number
N/A
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
CUSTOMER STATED THAT THE WASH STATION OVERFLOWED WHEN ATTEMPTED TO WASH THE PROBE ON THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEMS. LEAKING HARDWARE COMPONENT COULD POTENTIALLY IMPACT SAMPLE RESULTS BY EITHER CONTAMINATION OR DILUTION EFFECT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES. 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 ASSOCIATED WITH THIS EVENT. THE CUSTOMER REVIEWED THE MSDS AND THE FACILITY HAS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE. ON (B)(6) 2012, A FIELD SERVICE ENGINEER ((FSE) FOUND SAMPLE PROBE WASH STATION OVERFLOWED DUE TO CLOGGED WASTE FILTER. THE FSE REPLACED THE FILTER WHICH RESOLVED ISSUE. THE CAUSE OF THE LEAK WAS DUE TO CLOGGED WASTE FILTER.