BD FACSLYRIC¿

Additional Manufacturer Narrative

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.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD FACSLYRIC¿, CARRYOVER WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE SAMPLES CONTAMINATED? CARRYOVER HAPPENED ON PATIENT SAMPLES? WERE THERE ANY ERRONEOUS RESULTS ON PATIENT SAMPLES? IF SO, WERE THE ERRONEOUS RESULTS REPORTED OUT TO A CLINICIAN? THE CUSTOMER REPLIED THAT THERE IS A SMALL RISK THAT CARRYOVER COULD HAVE OCCURRED BUT THEY CAN´T RERUN OLD SAMPLES TO CHECK IT. I HAVE A QUESTION ABOUT THE WATER TUBE ON THE TUBE HOLDER OF THE LYRIC INSTRUMENT. THIS WEEK, WE HAVE NOTICED THAT THE WATER TUBE HAVE TAKEN SOME COLOR OF BLOOD, AFTER WE HAVE DONE THE ANALYSIS OF OUR SAMPLES, EACH DAY. THIS HAVE NOT HAPPENED BEFORE. SO MY QUESTION IS, IF WE HAVE TO DO ANYTHING ON THE INSTRUMENT BECAUSE OF THIS? IT SEEMS LIKE ITS DIRTY OR SOMETHING?

Additional Manufacturer Narrative

BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF SAMPLE CARRYOVER WAS CONFIRMED. THE POTENTIAL CAUSE WAS DETERMINED TO BE A FAULTY FLUIDICS RESTRICTOR. THE FIELD SERVICE ENGINEER INVESTIGATED THE ISSUE AND REPLACED THE RESTRICTOR, WHICH RESOLVED THE ISSUE AND RETURNED THE INSTRUMENT TO OPERATIONAL STATUS. THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT AND NO USER OR PATIENT WAS HARMED OR INJURED. THE COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE THE COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION. DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD FACSLYRIC¿, CARRYOVER WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE SAMPLES CONTAMINATED? CARRYOVER HAPPENED ON PATIENT SAMPLES? WERE THERE ANY ERRONEOUS RESULTS ON PATIENT SAMPLES? IF SO, WERE THE ERRONEOUS RESULTS REPORTED OUT TO A CLINICIAN? THE CUSTOMER REPLIED THAT THERE IS A SMALL RISK THAT CARRYOVER COULD HAVE OCCURRED BUT THEY CAN´T RERUN OLD SAMPLES TO CHECK IT. I HAVE A QUESTION ABOUT THE WATER TUBE ON THE TUBE HOLDER OF THE LYRIC INSTRUMENT. THIS WEEK, WE HAVE NOTICED THAT THE WATER TUBE HAVE TAKEN SOME COLOR OF BLOOD, AFTER WE HAVE DONE THE ANALYSIS OF OUR SAMPLES, EACH DAY. THIS HAVE NOT HAPPENED BEFORE. SO MY QUESTION IS, IF WE HAVE TO DO ANYTHING ON THE INSTRUMENT BECAUSE OF THIS? IT SEEMS LIKE ITS DIRTY OR SOMETHING?

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF BD FACSLYRIC¿, CARRYOVER WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE SAMPLES CONTAMINATED? CARRYOVER HAPPENED ON PATIENT SAMPLES? WERE THERE ANY ERRONEOUS RESULTS ON PATIENT SAMPLES? IF SO, WERE THE ERRONEOUS RESULTS REPORTED OUT TO A CLINICIAN? THE CUSTOMER REPLIED THAT THERE IS A SMALL RISK THAT CARRYOVER COULD HAVE OCCURRED BUT THEY CAN´T RERUN OLD SAMPLES TO CHECK IT. I HAVE A QUESTION ABOUT THE WATER TUBE ON THE TUBE HOLDER OF THE LYRIC INSTRUMENT. THIS WEEK, WE HAVE NOTICED THAT THE WATER TUBE HAVE TAKEN SOME COLOR OF BLOOD, AFTER WE HAVE DONE THE ANALYSIS OF OUR SAMPLES, EACH DAY. THIS HAVE NOT HAPPENED BEFORE. SO MY QUESTION IS, IF WE HAVE TO DO ANYTHING ON THE INSTRUMENT BECAUSE OF THIS? IT SEEMS LIKE ITS DIRTY OR SOMETHING?

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H.6 IMDRF ANNEX B: B21, H.6 IMDRF ANNEX C: C21, H.6 IMDRF ANNEX D: D16.