UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

Description of Event or Problem

THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT ERRONEOUS RESULTS FOR PHOSPHORUS (PHOSM) AND SODIUM (NA) FOR ONE (1) PATIENT SAMPLE GENERATED ON THEIR UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. BASED ON THE ERRONEOUS PHOSM RESULT, THE PATIENT WAS ADMINISTERED TREATMENT FOR LOW PHOSPHORUS. THE CUSTOMER REPORTED IT WAS UNKNOWN IF THE PATIENT WAS AFFECTED BY THE TREATMENT. THE CUSTOMER REPORTED THAT QUALITY CONTROL (QC) RESULTS WERE RECOVERING WITHIN THE LABORATORY'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. THE CUSTOMER REASSAYED THE PATIENT SAMPLE ON ANOTHER ANALYZER AND OBTAINED HIGHER RESULTS. AN AMENDED REPORT WAS GENERATED AND REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE OBSERVED THAT THE MODULAR CHEMISTRY SAMPLE SYRINGE WAS NOT MOVING UP AND DOWN AND THAT THERE WAS NO ERROR MESSAGE FLAG ON THE MONITOR OR IN THE EVENT LOG. THE FSE OBSERVED THAT THE COUPLER BETWEEN THE MODULAR CHEMISTRY SAMPLE DRIVE MOTOR AND THE SYRINGE WAS LOOSE. THIS CAUSED THE MOTOR TO TURN WITHOUT DRIVING THE SYRINGE. THE FSE RESET AND TIGHTENED THE COUPLER. THE FSE PERFORMED CALIBRATIONS, RAN QUALITY CONTROLS, AND A PRECISION ANALYSIS. ALL RESULTS RECOVERED WITHIN ESTABLISHED RANGES. THE EVENT DESCRIBED IN THIS MEDWATCH REPORT IS RELATED TO FOUR OTHER EVENTS WHICH OCCURRED AT THE TIME OF THIS EVENT. THE RELATED MEDWATCH REPORT NUMBERS ARE: 2050012-2011-04041, 2050012-2011-04079, 2050012-2011-04080, 2050012-2011-04082.