BD FACS¿ LYSE WASH ASSISTANT

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES. REPORTING OFFICE CONTACT: (B)(6). MANUFACTURING SITE CONTACT: (B)(6). H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE INCOMPLETE LYSING WAS CONFIRMED. CONFIRMED >. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE: THE POTENTIAL CAUSE WAS DETERMINED TO BE DEFECTIVE VALVE UNIT AND CLOGGED CELL WASH. THE DEVICE HISTORY RECORD WAS REVIEWED TO CONFIRM THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE FIELD SERVICE REPRESENTATIVE PERFORMED A SERIES OF WORKS INCLUDING REPLACEMENT OF THE VALVE UNIT AND CELL WASH ASSEMBLY. AFTER THE REPLACEMENT, A SERIES OF TESTS AND VERIFICATIONS WERE PERFORMED, AND THE INSTRUMENT WAS CONFIRMED TO BE OPERATING AS PER SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT THERE WERE ERRONEOUS RESULTS ACQUIRED. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: SAMPLES DO NOT LYSE PROPERLY AND REMAIN RED. THE PROBLEM OCCURS IN ALL SAMPLES IN A RACK.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT TERE WERE ERRONEOUS RESULTS ACQUIRED. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: SAMPLES DO NOT LYSE PROPERLY AND REMAIN RED. THE PROBLEM OCCURS IN ALL SAMPLES IN A RACK.