UNICEL DXC 800 SYNCHRON SYSTEM
Received Nov 18, 2011 · Event occurred Oct 25, 2011
Report 2050012-2011-07622 · MDR key 2342607
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman Coulter, Inc.Model number
DXC 800 PROCatalog number
A11812
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INSTRUMENT ISSUE WAS RESOLVED WHEN THE FIELD SERVICE ENGINEER REPLACED THE PHOSPHORUS CUP MODULE. (B)(4).
Description of Event or Problem
CUSTOMER CALLED TO REPORT THAT THE UNICEL DXC 800 SYNCHRON SYSTEM GENERATED FALSELY LOW PHOSPHORUS RESULTS FOR EIGHT PATIENTS. THE CUSTOMER TECHNICAL SPECIALIST REVIEWED CUSTOMER'S PROSERVICE ACCOUNT AND FOUND THAT THE QUALITY CONTROLS HAD ERRATIC RESULTS. ON THE FOLLOWING DAY, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND REPLACED THE PHOSPHORUS CUP MODULE. THE FSE THEN VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE. CUSTOMER STATED THAT ALTHOUGH ERRONEOUS RESULTS WERE GENERATED, THEY WERE NOT REPORTED OUTSIDE THE LABORATORY; THEREFORE, PATIENT TREATMENT WAS NOT AFFECTED.