UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING A SUPPRESSED LACTATE (LACT) RESULT WITH RX ABS HI (REACTION ABSORBANCE HIGH) FLAG GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM ON A NEAT SAMPLE DRAW FROM A PATIENT THAT WAS INTOXICATED WITH ETHYLENE GLYCOL. THE LAB TECHNICIAN DILUTED THE SAMPLE AND THE RESULT YIELDED A VALUE OF 4.1MMOL/L. THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY AROUND MIDNIGHT OF (B)(6) 2011. IN THE MORNING OF (B)(6) 2011, THE LAB TECHNICIAN NOTIFIED THE BIOCHEMIST OF THE RESULTS AND THE BIOCHEMIST INSTRUCTED THE LAB TECHNICIAN TO RERUN THE SAMPLE WITH MULTIPLE DILUTIONS. WHEN THE BIOCHEMIST WAS NOTIFIED THAT THE PATIENT WAS INTOXICATED WITH ETHYLENE GLYCOL, HE REVIEWED THE DATA AND MANUALLY CALCULATED THE LACT RESULT WHICH YIELDED A VALUE OF 2.0 MMOL/L AND AMENDED THE ORIGINAL RESULT. THE BIOCHEMIST CONCLUDED THAT GLYCOLIC ACID COULD HAVE INTERFERED WITH THE LACTATE REACTION. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. PER THE CUSTOMER'S LABORATORY REFERENCE INTERVALS, BOTH THE ORIGINAL AND AMENDED RESULTS WERE WITHIN THE NORMAL RANGES. THERE WAS NO IMPACT TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

Additional Manufacturer Narrative

CONTROLS RUN BEFORE AND AFTER THE INCIDENT WERE WITHIN ESTABLISHED RANGES. THE ROOT CAUSE FOR THIS EVENT IS ATTRIBUTED TO SAMPLE INTERFERENCE (ETHYLENE GLYCOL).