UNICEL DXC 600 PRO SYNCHRON SYSTEM
Received Mar 31, 2015 · Event occurred Mar 7, 2015
Report 2050012-2015-00115 · MDR key 4646552
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman CoulterModel number
NACatalog number
A11810
Lot number
NA
Product problems
- Fluid/Blood Leak
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THE UNICEL DXC 600 PRO SYNCHRON SYSTEM GENERATED ERRATIC AND SUPPRESSED RESULTS FOR BLOOD UREA NITROGEN (BUN) FOR PATIENT AND QUALITY CONTROL SAMPLES. CUSTOMER ALSO REPORTED REAGENT PROBE A WAS LEAKING. CUSTOMER REPORTED THE LEAK WAS ABOUT 15ML AND CONTAINED TO UNDER THE HOME POSITION OF THE REAGENT PROBE A. NO ERRONEOUS BUN RESULTS WERE REPORTED OUT OF THE LAB AND NO CHANGE IN TREATMENT OR HARM TO PATIENTS. NO EXPOSURE REPORTED. CUSTOMER WAS WEARING GLOVES.
Additional Manufacturer Narrative
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. FSE DETERMINED THE CAUSE OF THE ERRATIC AND SUPPRESSED BUN PATIENT AND QC RESULTS AS WELL AS THE REAGENT PROBE A LEAK WAS FROM REAGENT PROBE A COLLAR WASH VALVE. SERVICE REPLACED THE COLLAR WASH VALVE AND THAT RESOLVED THE ISSUE.