BD FACSLYRIC¿

Additional Manufacturer Narrative

THE FOLLOWING FIELD WAS UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX G: G07003. H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE POTENTIAL CAUSE AND/OR RESOLUTION COULD NOT BE DETERMINED DUE TO THE CUSTOMER STATING THEY HAVE A GAP IN THEIR CONTRACT ON THIS INSTRUMENT AND DO NOT WANT THE WORK DONE AT THIS TIME. THE SERVICE TEAM ATTEMPTED TO CONTACT THE CUSTOMER SEVERAL TIMES AND THERE WAS NO RESPONSE. ALTHOUGH THE INSTRUMENT IS USED FOR DIAGNOSTIC TESTING, NO IMPACT TO CUSTOMER AND PATIENT HEALTH OR SAFETY WAS REPORTED.

Description of Event or Problem

IT WAS REPORTED THAT CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT INSTRUMENT HAS HIGH CARRYOVER. 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 - GO TO QUESTION #2. CARRYOVER BETWEEN PATIENT SAMPLES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. INSTRUMENT HAS HIGH CARRYOVER.

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 CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT INSTRUMENT HAS HIGH CARRYOVER. 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 - GO TO QUESTION #2. CARRYOVER BETWEEN PATIENT SAMPLES 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. INSTRUMENT HAS HIGH CARRYOVER.