SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT

Additional Manufacturer Narrative

SERVICE WAS NOT DISPATCHED AS THE ROOT CAUSE WAS IDENTIFIED DURING BECKMAN COULTER INC. CUSTOMER TECHNICAL SERVICE TROUBLESHOOTING VIA PHONE. INVESTIGATION REVEALED THAT THE CUSTOMER HAD NOT PREPARED THE SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER ALT REAGENT KIT CORRECTLY. THEY HAD NOT TRANSFERRED THE A-REAGENT BOTTLE INTO COMPARTMENT A OF THE REAGENT CARTRIDGE. THE INSTRUCTIONS FOR USE, WHICH DESCRIBE HOW TO PREPARE THE REAGENT KIT WERE PRESENT IN THE REAGENT KIT PACKAGING.

Description of Event or Problem

A CUSTOMER REPORTED THAT ERRONEOUSLY LOW ALANINE TRANSAMINASE (ALT) RESULTS WERE GENERATED FROM A UNICEL DXC 600 SYNCHRON SYSTEM UPON THE USAGE OF A NEWLY INSTALLED SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER ALT REAGENT KIT. THE CUSTOMER WAS ADVISED TO PREPARE A NEW ALT REAGENT KIT AND RERUN THE SUSPECT RESULTS FOR THE EVENT TIMEFRAME. THE CUSTOMER REPEATED THE QUESTIONABLE SAMPLES ON A SECOND INSTRUMENT. OUT OF 15 SUSPECT PATIENT SAMPLE RESULTS, THREE WERE IDENTIFIED AS ERRONEOUS BASED UPON REPEAT TEST RESULTS. THE INITIAL, ERRONEOUS ALT RESULTS WERE GENERATED ON A SINGLE, OVERNIGHT SHIFT SPANNING (B)(6) 2011 AND (B)(64) 2011. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENTS ASSOCIATED OR ATTRIBUTED TO THIS EVENT.