BD FACSDUET¿ SAMPLE PREP

Additional Manufacturer Narrative

H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE BY CUSTOMER THAT FACSDUET VERSUS SYSMEX ABSOLUTE NUMBER COMPARISON % DIFFERENCE INCREASED WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: DEVICE HISTORY RECORD (DHR) REVIEW. THE FACSDUET SYSTEM WAS PERFORMING AS REQUIRED. THE POTENTIAL CAUSE IS NOT DETERMINED. BD CANNOT MAKE CLAIMS ABOUT % DIFFERENCE SIMILARITY TO ANOTHER NON-BD SYSTEM. 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 DURING USE WITH BD FACSDUET¿ SAMPLE PREP THERE WERE ERRONEOUS LYMPHOCYTE ABSOLUTE COUNT RESULTS. RESULTS WERE REPORTED TO THE CLINICIAN, HOWEVER, THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: CUSTOMER PERFORMED DUET VERSUS SYSMEX LYMPHOCYTE ABSOLUTE NUMBER COMPARISON ON PATIENT SAMPLES. SINCE 2022 THEY OBSERVED AN INCREASE OF THE DIFFERENCE BETWEEN DUET VS SYSMEX DATA. THEY REJECT DATA WHEN THE DIFFERENCE BETWEEN DUET VERSUS SYSMEX IS OVER 0.3 G/L (ABSOLUTE NUMBER) OR OVER 15% (RELATIVE DIFFERENCE). IN 2022 AND 2023 THE % OF REJECTED SAMPLES SIGNIFICANTLY INCREASE (FROM 7% REJECTED PATIENT DATA IN JUNE/JULY 2021 TO 41% IN SEPT 2023). ACCORDING TO THE CUSTOMER THIS IS NOT RELATED TO TRUCOUNT ISSUE BECAUSE THE SAME TRUCOUNT LOTS HAVE BEEN USED WITH MANUAL PREPARATION WITHOUT ANY ISSUE (SYSMEX AND MANUAL DATA VERY CLOSE).

Additional Manufacturer Narrative

E.1. INITIAL REPORTER PHONE #: (B)(6). G.5. THE EVENT DESCRIBED OCCURRED ON AN CE-IVD INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACSDUET¿ SAMPLE PREP THERE WERE ERRONEOUS LYMPHOCYTE ABSOLUTE COUNT RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: CUSTOMER PERFORMED DUET VERSUS SYSMEX LYMPHOCYTE ABSOLUTE NUMBER COMPARISON ON PATIENT SAMPLES. SINCE 2022 THEY OBSERVED AN INCREASE OF THE DIFFERENCE BETWEEN DUET VS SYSMEX DATA. THEY REJECT DATA WHEN THE DIFFERENCE BETWEEN DUET VERSUS SYSMEX IS OVER 0.3 G/L (ABSOLUTE NUMBER) OR OVER (B)(4). (RELATIVE DIFFERENCE). IN 2022 AND 2023 THE (B)(4). ACCORDING TO THE CUSTOMER THIS IS NOT RELATED TO TRUCOUNT ISSUE BECAUSE THE SAME TRUCOUNT LOTS HAVE BEEN USED WITH MANUAL PREPARATION WITHOUT ANY ISSUE (SYSMEX AND MANUAL DATA VERY CLOSE).

Additional Manufacturer Narrative

THE FOLLOWING FIELD HAS BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT DURING USE WITH BD FACSDUET¿ SAMPLE PREP THERE WERE ERRONEOUS LYMPHOCYTE ABSOLUTE COUNT RESULTS. RESULTS WERE REPORTED TO THE CLINICIAN, HOWEVER, THERE WAS NO REPORT OF PATIENT IMPACT. H.4. DEVICE MANUFACTURE DATE: 2020-01-27. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1 - REPORTING OFFICE CONTACT - (B)(4). G.1 - MANUFACTURING SITE CONTACT - (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACSDUET¿ SAMPLE PREP THERE WERE ERRONEOUS LYMPHOCYTE ABSOLUTE COUNT RESULTS. RESULTS WERE REPORTED TO THE CLINICIAN, HOWEVER, THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: CUSTOMER PERFORMED DUET VERSUS SYSMEX LYMPHOCYTE ABSOLUTE NUMBER COMPARISON ON PATIENT SAMPLES. SINCE 2022 THEY OBSERVED AN INCREASE OF THE DIFFERENCE BETWEEN DUET VS SYSMEX DATA. THEY REJECT DATA WHEN THE DIFFERENCE BETWEEN DUET VERSUS SYSMEX IS OVER 0.3 G/L (ABSOLUTE NUMBER) OR OVER 15% (RELATIVE DIFFERENCE). IN 2022 AND 2023 THE % OF REJECTED SAMPLES SIGNIFICANTLY INCREASE (FROM 7% REJECTED PATIENT DATA IN (B)(6) 2021 TO 41% IN (B)(6) 2023) ACCORDING TO THE CUSTOMER THIS IS NOT RELATED TO TRUCOUNT ISSUE BECAUSE THE SAME TRUCOUNT LOTS HAVE BEEN USED WITH MANUAL PREPARATION WITHOUT ANY ISSUE (SYSMEX AND MANUAL DATA VERY CLOSE).