UNICEL® DXC 800 SYNCHRON® SYSTEM

Additional Manufacturer Narrative

BECKMAN COULTER INC. CUSTOMER TECHNICAL SERVICES GUIDED THE CUSTOMER THROUGH INSTRUMENT TROUBLESHOOTING. THE CUSTOMER PERFORMED A CUP CLEANING PROCEDURE, A LAMP CALIBRATION, AND AN INSTRUMENT CALIBRATION AND ASSAY QUALITY CONTROL ASSESSMENT. THE CUSTOMER ADVISED THAT THEY WOULD CONTACT BECKMAN COULTER IF THE TROUBLESHOOTING DID NOT RESOLVE THE CUSTOMER. NO CUSTOMER FEEDBACK REPORTS HAS BEEN RECEIVED FROM THIS CUSTOMER SINCE THE TIME OF THIS EVENT WITH A SIMILAR ISSUE. ALTHOUGH ADJUSTMENTS WERE MADE TO THE INSTRUMENT BEFORE RETURNING IT INTO SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT ON (B)(6) 2011 AN ERRONEOUSLY LOW PHOSPHORUS (PHOSM) RESULT WAS GENERATED FROM A UNICEL DXC 800 SYNCHRON SYSTEM FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS RELEASED FROM THE LABORATORY AND THE PATIENT RECEIVED MEDICAL TREATMENT BECAUSE OF THE LOW RESULT. THE DETAILS OF PATIENT TREATMENT ARE CURRENTLY UNKNOWN. THE SAMPLE WAS RETESTED ON THE SAME INSTRUMENT, AS WELL AS ANOTHER INSTRUMENT. THE REPEAT RESULTS WERE HIGHER. NO SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER. INSTRUMENT PHOSM QUALITY CONTROL RESULTS DURING THE TIMEFRAME OF THE EVENT WERE WITHIN CUSTOMER SPECIFICATIONS.