UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER

Description of Event or Problem

CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO SEVERAL ERRONEOUS LOW PHOSPHOROUS (PHOS) PATIENT RESULTS, WHICH WERE GENERATED BY UNICEL DXC 800 PRO CHEMISTRY ANALYZER. ONE PATIENT WAS TREATED BASED ON THE ERRONEOUS RESULTS, JUST BEFORE THE AMENDED RESULT WAS CALLED IN. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. AN AMENDED REPORTS WERE ISSUED.

Additional Manufacturer Narrative

THE SAMPLES WERE SERUM. CALIBRATION APPEARS ACCEPTABLE BEFORE THE EVENT. QC CHART FROM THE PREVIOUS WEEK RESULTED IN ONE LOW AND TWO HIGH PHOSM FLIERS. A FIELD SERVICE ENGINEER (FSE) REPLACED THE PHOSM MODULE AND ASSOCIATED TUBING. A CLEAR ROOT CAUSE CAN NOT BE IDENTIFIED FOR THIS EVENT.