BD FACSCANTO¿

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF AN ERROR WINDOW POPPING UP ON DIVA SOFTWARE AFTER THE END OF CERTAIN PANELS BUT NOT ALL RUNS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE INVESTIGATION WAS PERFORMED BASED ON THE REVIEW OF COMPLAINT TREND, RISK ANALYSIS, AND REVIEW OF CUSTOMER PROVIDED INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED AND TESTING WAS STILL ABLE TO CONTINUE DURING USE WITH THE BD FACSCANTO¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE AN ERROR WINDOW POPPING UP ON OUR DIVA SOFTWARE AFTER THE END OF CERTAIN PANELS BUT NOT ALL RUNS (LEUKEMIA PANELS, RITUXIMAB PANELS, ETC.) ALSO, OUR SOFTWARE SEEMS TO BE RUNNING SLOW AND HAS TROUBLE ACCESSING EXPORT FOLDER FILES WHEN DOING THE CAROUSEL SETUP. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: SPOKE WITH CUSTOMER AND THEY ARE HAVING ISSUES RUNNING SOME OF THEIR PANELS. SOME PANELS WORK SOME DO NOT. SUSPECT THE PANELS ARE CORRUPT. CUSTOMER WOULD LIKE THE FSE TO LOOK AT IT ADDITIONAL INFORMATION: 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.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.4. MEDICAL DEVICE SERIAL #: (B)(6). D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H.6 IMDRF ANNEX B: B21. H.6 IMDRF ANNEX C: C21. H.6 IMDRF ANNEX D: D16. G.1. REPORTING OFFICE: (B)(4). G.1. REPORTING OFFICE CONTACT: (B)(4) - MDR. G.1. MANUFACTURING SITE CONTACT: (B)(4) - MDR.

Description of Event or Problem

IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED AND TESTING WAS STILL ABLE TO CONTINUE DURING USE WITH THE BD FACSCANTO¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE AN ERROR WINDOW POPPING UP ON OUR DIVA SOFTWARE AFTER THE END OF CERTAIN PANELS BUT NOT ALL RUNS (LEUKEMIA PANELS, RITUXIMAB PANELS, ETC.) ALSO, OUR SOFTWARE SEEMS TO BE RUNNING SLOW AND HAS TROUBLE ACCESSING EXPORT FOLDER FILES WHEN DOING THE CAROUSEL SETUP. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: SPOKE WITH CUSTOMER AND THEY ARE HAVING ISSUES RUNNING SOME OF THEIR PANELS. SOME PANELS WORK SOME DO NOT. SUSPECT THE PANELS ARE CORRUPT. CUSTOMER WOULD LIKE THE FSE TO LOOK AT IT. ADDITIONAL INFORMATION: 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.

Description of Event or Problem

IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED AND TESTING WAS STILL ABLE TO CONTINUE DURING USE WITH THE BD FACSCANTO¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE AN ERROR WINDOW POPPING UP ON OUR DIVA SOFTWARE AFTER THE END OF CERTAIN PANELS BUT NOT ALL RUNS (LEUKEMIA PANELS, RITUXIMAB PANELS, ETC.) ALSO, OUR SOFTWARE SEEMS TO BE RUNNING SLOW AND HAS TROUBLE ACCESSING EXPORT FOLDER FILES WHEN DOING THE CAROUSEL SETUP. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: SPOKE WITH CUSTOMER AND THEY ARE HAVING ISSUES RUNNING SOME OF THEIR PANELS. SOME PANELS WORK SOME DO NOT. SUSPECT THE PANELS ARE CORRUPT. CUSTOMER WOULD LIKE THE FSE TO LOOK AT IT ADDITIONAL INFORMATION: 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.

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.