BD FACSLYRIC¿

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 DURING USE WITH BDFACSLYRIC¿ 5 SAMPLES HAD UNEXPECTEDLY HIGH ABSOLUTE NUMBERS OF LYMPOCYTES THAT WERE REPORTED TO CLINICIAN. IT WAS NOT REPORTED HOW MANY PATIENTS WERE AFFECTED, HOWEVER, IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE AUTHORIZING RESULTS, I AGAIN SAW MANY UNEXPECTEDLY HIGH ABSOLUTE NUMBERS OF LYMPHOCYTES (10-30% HIGHER). SO CX DOUBLE-PLAYED 5 SAMPLES AGAIN ON FRIDAY AND ALL 5 ARE APPROXIMATELY 15% HIGHER IN LYRIC 1 THAN LYRIC 2. I STILL FIND THAT DISTURBING, SO LYRIC 1 STILL GIVES TOO HIGH ABSOLUTE NUMBERS. WE NOW SWITCH BACK TO THE LYRIC 2 FOR THE LYSP AND CD4/8 MEASUREMENTS. BUT THIS STILL NEEDS TO BE RESOLVED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BDFACSLYRIC¿ 5 SAMPLES HAD UNEXPECTEDLY HIGH ABSOLUTE NUMBERS OF LYMPOCYTES THAT WERE REPORTED TO CLINICIAN. IT WAS NOT REPORTED HOW MANY PATIENTS WERE AFFECTED, HOWEVER, IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE AUTHORIZING RESULTS, I AGAIN SAW MANY UNEXPECTEDLY HIGH ABSOLUTE NUMBERS OF LYMPHOCYTES (10-30% HIGHER). SO CX DOUBLE-PLAYED 5 SAMPLES AGAIN ON FRIDAY AND ALL 5 ARE APPROXIMATELY 15% HIGHER IN LYRIC 1 THAN LYRIC 2. I STILL FIND THAT DISTURBING, SO LYRIC 1 STILL GIVES TOO HIGH ABSOLUTE NUMBERS. WE NOW SWITCH BACK TO THE LYRIC 2 FOR THE LYSP AND CD4/8 MEASUREMENTS. BUT THIS STILL NEEDS TO BE RESOLVED.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF HIGH LYMPHOCYTE COUNT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE ISSUE WAS DETERMINED TO BE A DEFECTIVE BLUE LASER. THE FSE REPLACED THE BLUE LASER & PERFORMED OPTICS ALIGNMENT, AFTER WHICH THE INSTRUMENT WAS FOUND TO BE FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT. REVIEW OF THE DHR CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION. 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.