BD FACSLYRIC¿

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION. H.6 IMDRF ANNEX: B21. H.6 IMDRF ANNEX: C21. H.6 IMDRF ANNEX: D16.

Description of Event or Problem

IT WAS REPORTED THAT CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION CHECKLIST: 1.WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN -GOT TO QUESTION #2: CARRYOVER BETWEEN PATIENT SAMPLES CARRY OVER ISSUE.

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.

Description of Event or Problem

IT WAS REPORTED THAT CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION CHECKLIST: 1.WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN -GOT TO QUESTION #2: -CARRYOVER BETWEEN PATIENT SAMPLES CARRY OVER ISSUE

Description of Event or Problem

IT WAS REPORTED THAT CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION CHECKLIST: 1.WERE PATIENT SAMPLES CONTAMINATED OR WAS THEIR CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN GOT TO QUESTION #2: CARRYOVER BETWEEN PATIENT SAMPLES. CARRY OVER ISSUE.

Additional Manufacturer Narrative

H6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE CARRYOVER WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE POTENTIAL CAUSE FOR THE CARRYOVER COULD NOT BE DETERMINED. THE CUSTOMER REPORTED A COMPLAINT REGARDING CARRYOVER. THEY REPORTED THAT THE POPULATIONS WERE MOVING INTERMITTENTLY. THE ISSUE COULD NOT BE REPRODUCED. THE SERVICE TEAM GUIDED THE CUSTOMER TO TROUBLESHOOT. THE CUSTOMER CLEANED THE INSTRUMENT AND PURGED THE FILTER. THEY RAN CLEANING DETERGENT FOR 5 MINUTES. THEY RAN WATER AFTER RUNNING BEADS AND FOUND NO RESIDUALS. THEY VERIFIED THE VACUUM AND WASTE PUMP CIRCUIT. AFTER THE CLEANING, THE INSTRUMENT WAS TESTED AND WAS CONFIRMED TO BE PERFORMING ACCORDING TO SPECIFICATIONS.