BD FACSLYRIC¿

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IF THERE WAS ANY CONTAMINATION THAT INVOLVES PATIENT SAMPLE? NO CONTAMINATION REPORTED; WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? AFTER THE USER RE-RAN THE SAMPLE IN MANUAL MODE, THE CORRECT SAMPLE DATA WAS ACQUIRED; WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? NO CARRYOVER WAS REPORTED. IT WAS REPORTED BY THE CUSTOMER THAT THE INSTRUMENT LOST EVENTS/POPULATIONS IN ONE TUBE'S ACQUISITION ON THE SAMPLE RACK, WHILE THE OTHER TUBES RAN JUST FINE.

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). INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF INTERMITTENT LOSS OF POPULATIONS FROM THEIR SAMPLE WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING INTERMITTENT LOSS OF POPULATIONS IN THEIR SAMPLE WERE DUE TO MULTIPLE WORN PARTS. THE ISSUES WERE RESOLVED AFTER PARTS WERE REPLACED AND UNDERWENT OUR NORMAL SERVICE MAINTENANCE PROCESS. NO FURTHER PROBLEMS WERE NOTED. THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. 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.

Additional Manufacturer Narrative

B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. E.1. INITIAL REPORTER ADDRESS 1: (B)(6). 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 ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. IF THERE WAS ANY CONTAMINATION THAT INVOLVES PATIENT SAMPLE? NO CONTAMINATION REPORTED; 2. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? AFTER THE USER RE-RAN THE SAMPLE IN MANUAL MODE, THE CORRECT SAMPLE DATA WAS ACQUIRED; 3. WHETHER CARRYOVER HAPPENED ON PATIENT SAMPLES? NO CARRYOVER WAS REPORTED. IT WAS REPORTED BY THE CUSTOMER THAT THE INSTRUMENT LOST EVENTS/POPULATIONS IN ONE TUBE'S ACQUISITION ON THE SAMPLE RACK, WHILE THE OTHER TUBES RAN JUST FINE.