UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A FALSE LOW ALANINE AMINOTRANSFERASE (ALT) RESULT GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. THE INITIAL ALT RESULT OF 4 IU/L WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. CUSTOMER RE-SPUN AND RERAN THE SAMPLE WHICH YIELDED AN ALT RESULT OF 638 IU/L. THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

Additional Manufacturer Narrative

THE SAMPLE WAS COLLECTED IN A 13X100MM GREINER TUBE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE NOTICED THE SYSTEM GENERATED MULTIPLE "OBSTRUCTION DETECTION" WARNINGS. THE FSE OBSERVED GREY RUBBER IN TUBES AND INSTALLED A NEW BLADE. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT. HOWEVER, UPON RECUR ANY CHEMISTRY COULD BE AFFECTED, INCLUDING PIVOTAL ASSAY. TREATMENT COULD BE INITIATED OR WITHHELD BASED ON THE ERRONEOUS RESULTS OF PIVOTAL CHEMISTRIES THAT MAY CAUSE OR CONTRIBUTE TO SERIOUS INJURY TO THE PATIENT. ROOT CAUSE IS UNKNOWN. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.