BD FACSLYRIC¿

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD ACQUIRED A SAMPLE WITHOUT THE DATA BEING SAVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER NOTED THAT A SAMPLE WAS ACQUIRED WITHOUT THE DATA BEING SAVED. OTHER WELLS WERE ACQUIRED WITHOUT ANY ISSUES. LOG FILE ANALYSIS DOES NOT SHOW ANY INDICATIONS DURING THE RUN OF THE NAMED SAMPLE. ONLY NOTATION OTHER THAN THE SETTINGS OF THE PARAMETER VOLTAGES AND LASER CHARACTERISTICS IS THE BELOW ONE. WHICH ALSO IS FOUND FOR OTHER RUNS WHERE NO ISSUES WERE REPORTED ON. ESCALATION CREATED AS NO ROOT CAUSE CAN BE FOUND FOR SINGLE OCCURRENCE OF NO DATA BEING CAPTURED. NO FSE REQUIRED AS NO FURTHER ISSUES TAKE PLACE. SHR IS UPLOADED TO CASE, YET NO DETAILS OR ERRORS FOUND ON THE MOMENT OF THE OCCURRENCE. MISSING OF RECORDING OF DATA WHILE SAMPLE IS ACQUIRED HAS BEEN SEEN BEFORE AND CAUSES CONCERN OF MISSING PATIENT DATA.

Description of Event or Problem

IT WAS REPORTED THAT BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD ACQUIRED A SAMPLE WITHOUT THE DATA BEING SAVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER NOTED THAT A SAMPLE WAS ACQUIRED WITHOUT THE DATA BEING SAVED. OTHER WELLS WERE ACQUIRED WITHOUT ANY ISSUES. LOG FILE ANALYSIS DOES NOT SHOW ANY INDICATIONS DURING THE RUN OF THE NAMED SAMPLE. ONLY NOTATION OTHER THAN THE SETTINGS OF THE PARAMETER VOLTAGES AND LASER CHARACTERISTICS IS THE BELOW ONE. WHICH ALSO IS FOUND FOR OTHER RUNS WHERE NO ISSUES WERE REPORTED ON. ESCALATION CREATED AS NO ROOT CAUSE CAN BE FOUND FOR SINGLE OCCURRENCE OF NO DATA BEING CAPTURED. NO FSE REQUIRED AS NO FURTHER ISSUES TAKE PLACE. SHR IS UPLOADED TO CASE, YET NO DETAILS OR ERRORS FOUND ON THE MOMENT OF THE OCCURRENCE. MISSING OF RECORDING OF DATA WHILE SAMPLE IS ACQUIRED HAS BEEN SEEN BEFORE AND CAUSES CONCERN OF MISSING PATIENT DATA.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: 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: BECTON DICKINSON AND COMPANY BD BIOSCIENCES. G.1. REPORTING OFFICE CONTACT: FAHMY RAZAK - MDR. G.1. MANUFACTURING SITE CONTACT: FAHMY RAZAK - MDR.

Description of Event or Problem

IT WAS REPORTED THAT BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD ACQUIRED A SAMPLE WITHOUT THE DATA BEING SAVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER NOTED THAT A SAMPLE WAS ACQUIRED WITHOUT THE DATA BEING SAVED. OTHER WELLS WERE ACQUIRED WITHOUT ANY ISSUES. LOG FILE ANALYSIS DOES NOT SHOW ANY INDICATIONS DURING THE RUN OF THE NAMED SAMPLE. ONLY NOTATION OTHER THAN THE SETTINGS OF THE PARAMETER VOLTAGES AND LASER CHARACTERISTICS IS THE BELOW ONE. WHICH ALSO IS FOUND FOR OTHER RUNS WHERE NO ISSUES WERE REPORTED ON. ESCALATION CREATED AS NO ROOT CAUSE CAN BE FOUND FOR SINGLE OCCURRENCE OF NO DATA BEING CAPTURED. NO FSE REQUIRED AS NO FURTHER ISSUES TAKE PLACE. SHR IS UPLOADED TO CASE, YET NO DETAILS OR ERRORS FOUND ON THE MOMENT OF THE OCCURRENCE. MISSING OF RECORDING OF DATA WHILE SAMPLE IS ACQUIRED HAS BEEN SEEN BEFORE AND CAUSES CONCERN OF MISSING PATIENT DATA.

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE THAT THOUGH THE SAMPLE WAS ACQUIRED THE DATA WAS NOT BEING SAVED. THE CUSTOMER STATED THAT THOUGH OTHER WELLS WERE ACQUIRED WITHOUT ANY ISSUES, A SAMPLE WAS ACQUIRED WITHOUT DATA BEING SAVED WAS NOT DETERMINED. THE PROVIDED DATA WHICH INCLUDED PHOTO AND SYSTEM HEALTH REPORT WAS THOROUGHLY ANALYZED, HOWEVER THE ISSUE WAS NOT REPRODUCIBLE. THERE WAS NO IMPACT TO PATIENT OR USER AND THEY WEREN'T TREATED BASED IN IT. THE POTENTIAL CAUSE WAS NOT DETERMINED SINCE THE ISSUE WAS NOT REPRODUCIBLE.