MalfunctionCFN
IMMAGE IMMUNOCHEMISTRY SYSTEM
Received Apr 25, 2012 · Event occurred Apr 5, 2012
Report 2050012-2012-01037 · MDR key 2548783
Device
Generic name
Nephelometer, For Clinical Use
Manufacturer
Beckman Coulter, Inc.Model number
N/ACatalog number
A15445
Product problems
- Overfill
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2012 CUSTOMER REPORTED THAT THEY HAD REPLACED THE FILTER ON SAMPLE PROBE WASH STATION, ON THE IMMAGE 800 INSTRUMENT, AND IT OVERFLOWED. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THE FILTER WAS PLUGGED. FSE REPLACED THE FILTER AND THIS RESOLVED THE ISSUE. NO FURTHER PROBLEMS WERE REPORTED.
Additional Manufacturer Narrative
(B)(4).