BD FACSLYRIC¿

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD FACSLYRIC¿, ERRONEOUS RESULTS WERE OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES. 2. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? NO. THEY RERUN THE SAMPLE BECAUSE THE RESULTS WERE NOT NORMAL. NO CARRYOVER. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS RESULTS FOR PATIENT SAMPLES WERE NOT AS EXPECTED. THERE WAS NO IMPACT AS THE RESULT WAS CLEARLY NOT SHOWING ANY EXPECTED POPULATIONS AND RERUNS WERE MADE WITH SAMPLE SHOWING NORMAL RESULTS. ALL PATIENT RESULTS WERE DELIVERED IN TIME. CUSTOMER HAS REPORTED THEY HAD TO RERUN A SAMPLE ON THREE OCCASIONS AS THE RESULT WAS NOT AS EXPECTED. THIS WAS VERY CLEAR AND NO CONFUSION COULD TAKE PLACE. AFTER RERUNNING THE SAMPLE, THE RESULTS WERE AS EXPECTED. CUSTOMER WOULD LIKE TO UNDERSTAND IF THERE IS A POSSIBLE UNDERLYING ASPECT THAT REQUIRES ATTENTION.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - BECTON DICKINSON AND COMPANY BD BIOSCIENCES SAN JOSE CA, 95131; G.1 - REPORTING OFFICE CONTACT - (B)(4); G.1 - MANUFACTURING SITE CONTACT - (B)(4). H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR UNEXPECTED RESULTS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING : THE POTENTIAL CAUSE FOR THE UNEXPECTED RESULTS WAS A CLOG IN THE FLOWCELL. THE CUSTOMER REPORTED A COMPLAINT REGARDING UNEXPECTED RESULT. THE FSR PERFORMED A SERIES OF CHECKS IN THE FLUIDIC SUBSYSTEM AND CLEANED THE FLOWCELL. AFTER THE WORKS PERFORMED, THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING ACCORDING TO THE SPECIFICATIONS. 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD FACSLYRIC¿, ERRONEOUS RESULTS WERE OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES. 2. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? NO. THEY RERUN THE SAMPLE BECAUSE THE RESULTS WERE NOT NORMAL. NO CARRYOVER. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS RESULTS FOR PATIENT SAMPLES WERE NOT AS EXPECTED. THERE WAS NO IMPACT AS THE RESULT WAS CLEARLY NOT SHOWING ANY EXPECTED POPULATIONS AND RERUNS WERE MADE WITH SAMPLE SHOWING NORMAL RESULTS. ALL PATIENT RESULTS WERE DELIVERED IN TIME. CUSTOMER HAS REPORTED THEY HAD TO RERUN A SAMPLE ON THREE OCCASIONS AS THE RESULT WAS NOT AS EXPECTED. THIS WAS VERY CLEAR AND NO CONFUSION COULD TAKE PLACE. AFTER RERUNNING THE SAMPLE, THE RESULTS WERE AS EXPECTED. CUSTOMER WOULD LIKE TO UNDERSTAND IF THERE IS A POSSIBLE UNDERLYING ASPECT THAT REQUIRES ATTENTION.

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.