BD FACSCANTO¿ II FLOW CYTOMETER

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - BECTON DICKINSON AND COMPANY BD BIOSCIENCES SAN JOSE CA, 95131. G.1 - REPORTING OFFICE CONTACT - FAHMY RAZAK. G.1 - MANUFACTURING SITE CONTACT - FAHMY RAZAK. H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE REGARDING LOAD UNLOAD DETECTION ERROR WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE POTENTIAL CAUSE OF THE ISSUE WAS THAT THE TUBE SENSOR NEEDED ADJUSTMENT. THE DHR WAS REVIEWED TO CONFIRM THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A FIELD VISIT. THE FIELD SERVICE REPRESENTATIVE (FSR) CHECKED THE TUBE SENSOR VOLTAGE AND PERFORMED A READJUSTMENT.. AFTER THE ADJUSTMENTS PERFORMED, THE INSTRUMENT WAS TESTED AND CONFIRMED TO BE PERFORMING ACCORDING TO THE INSTRUMENT 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 AFTER USING BD FACSCANTO¿ II FLOW CYTOMETER ERROR MESSAGE WAS BYPASSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 4. IS THIS PRESTO ? NO. IT WAS REPORTED BY THE CUSTOMER THAT ERROR E060- LOAD UNLOAD DETECTION ERROR. ERROR IS HAPPENING INTERMITTENTLY, CYTOMETER WILL DISCONNECT AFTER THE ERROR AND IF THE ERROR IS NOT CAUGHT, THE WHOLE SAMPLE WILL BE ASPIRATED. CUSTOMER TRIED REBOOTING AND ISSUE PERSISTS.

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 AFTER USING BD FACSCANTO¿ II FLOW CYTOMETER ERROR MESSAGE WAS BYPASSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 4. IS THIS PRESTO ? NO. IT WAS REPORTED BY THE CUSTOMER THAT ERROR E060- LOAD UNLOAD DETECTION ERROR. ERROR IS HAPPENING INTERMITTENTLY, CYTOMETER WILL DISCONNECT AFTER THE ERROR AND IF THE ERROR IS NOT CAUGHT, THE WHOLE SAMPLE WILL BE ASPIRATED. CUSTOMER TRIED REBOOTING AND ISSUE PERSISTS.