ACQUITY UPLC SAMPLE ORGANIZER

Description of Event or Problem

BASED ON INFO REPORTED TO WATERS: (B)(4) 2013 -- THE CUSTOMER REQUESTED AN ON-SITE CONSULTATION FOR TRAINING REGARDING DATA ACQUISITION. ON (B)(6) 2013 -- DURING ON-SITE SERVICE, THE CUSTOMER REPORTED THAT THEY WERE CONCERNED THAT ONE OF THEIR INSTRUMENT OPERATORS HAD MANUALLY MODIFIED RESULTS. THE CUSTOMER STATED THAT THEY WERE NOT REPORTING ANY ISSUES WITH THE PERFORMANCE OF THE INSTRUMENT, BUT RATHER THE "OFF PROTOCOL" WAY THE RESULTS WERE HANDLED AFTER IT WAS ACQUIRED. THE CUSTOMER SAID THAT SOME OF THE UNACCEPTABLE RESULTS HAD BEEN RELEASED, DESPITE NOT MEETING THEIR OWN STANDARD OPERATING PROCEDURE AND ACCEPTANCE CRITERIA.

Additional Manufacturer Narrative

BASED ON THE INFO REPORTED BY THE CUSTOMER AND WATERS' OWN INVESTIGATION OF THE EVENT, THE ISSUE WAS CAUSED BY THE OPERATOR'S HANDLING OF THE RESULTS AFTER ACQUISITION, NOT AN ISSUE WITH THE INSTRUMENT OR THE RESULTS IT PROVIDED. ALTHOUGH WE CONSIDER THIS ISSUE TO BE CAUSED BY OPERATOR ERROR, WE ARE REPORTING THE EVENT BECAUSE THE LAB RELEASED POTENTIALLY INACCURATE RESULTS. HOWEVER, THERE IS NO INDICATION THAT ANY PT WAS INJURED OR THERAPY ALTERED. THE LAB DIR STATED THAT THE USER FACILITY WAS INVESTIGATING WHY THEIR OWN "RELEASE" CRITERIA HAD NOT BEEN FOLLOWED CORRECTLY AND THAT THEY WERE NOT REPORTING AN ISSUE WITH OUR EQUIPMENT. TRAINING REGARDING INSTRUMENT USE WAS PROVIDED TO THE CUSTOMER. ADDITIONALLY, THE CUSTOMER WAS DIRECTED TOWARD THE RELEVANT OPERATOR'S MANUALS. WE CONSIDER THIS INVESTIGATION TO BE COMPLETE. HOWEVER, SHOULD ADDITIONAL RELEVANT INFO BE REPORTED, WE WILL SUBMIT A SUPPLEMENTAL MDR.