ACT 5DIFF RINSE

Description of Event or Problem

THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) OBTAINING WHITE BLOOD COUNT (WBC) RESULTS BIAS LOW ON ALL QUALITY CONTROL (QC) ON THE COULTER AC T 5DIFF CP ANALYZER. THE CUSTOMER TECHNICAL SUPPORT (CTS) CONFIRMED THAT THE DILUENT AND ACT 5 DIFF RINSE REAGENT WERE REPLACED THE SECOND WEEK OF APRIL, AND THAT NO CALIBRATION ADJUSTMENTS HAD BEEN COMPLETED. NO PATIENT SAMPLES WERE RUN DURING THE TIME PERIOD THAT THE ISSUE WITH CONTROLS WAS IDENTIFIED UP TO THE TIME THAT THE INSTRUMENT UNDERWENT REPAIRS, AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN RELATION TO THIS EVENT. THIS MDR IS TO REPORT THE EVENT OCCURED ON (B)(6) 2013. PLEASE REFER TO MDR 1061932-2013-01146 WHICH COVERS THE EVENT OCCURRED ON (B)(6) 2013.

Additional Manufacturer Narrative

A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE REPLACED MULTIPLE HARDWARE COMPONENTS; HOWEVER, IT DID NOT RESOLVE THE PROBLEM. UPON FURTHER INSPECTION, THE FSE DISCOVERED THE INSTRUMENT WAS RUNNING WITH A CONTAMINATED ACT 5DIFF REAGENT WITH AN OPEN CONTAINER EXPIRATION DATE OF 07/18/2013. PER THE FSE, THE REAGENT HAD VISIBLE GROSS WHITE PRECIPITATE INSIDE THE BOTTLE. THE FSE CLEANED THE SYSTEM AND REPLACED THE REAGENT WITH A NEW BOTTLE (LOT NUMBER 13002C00357) WITH PRODUCT CLOSED CONTAINER EXPIRATION DATE OF 12/27/2013, RESOLVING THE CONTROL RECOVERY ISSUE. FAILURE MODE RELATED TO THE LOW WBC VOTE OUTS AND LOW WBC RESULTS ON CONTROLS WAS RELATED TO A CONTAMINATED ACT 5 DIFF RINSE REAGENT BOTTLE. (B)(4).