BD FACSLYRIC¿

Additional Manufacturer Narrative

E.1: (B)(6). 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 DURING USE OF BD FACSLYRIC¿ CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT AFTER THE LAST FSE VISIT WHERE THE SIT WAS ADJUSTED, THEY ARE NOW EXPERIENCING CARRY OVER AND HAVE TO RUN A TUBE OF WATER IN-BETWEEN SAMPLES AND THE DEAD VOLUME IS TO HIGH.

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING CARRYOVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE DEVICE HISTORY REVIEW, COMPLAINT TREND, AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING CARRYOVER IS DUE TO THE SAMPLE INJECTION TUBE (SIT). THE ISSUE WAS RESOLVED AFTER THE SIT WAS ADJUSTED AND THE INSTRUMENT WAS CALIBRATED. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD FACSLYRIC¿ CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT AFTER THE LAST FSE VISIT WHERE THE SIT WAS ADJUSTED, THEY ARE NOW EXPERIENCING CARRY OVER AND HAVE TO RUN A TUBE OF WATER IN-BETWEEN SAMPLES AND THE DEAD VOLUME IS TO HIGH.