BD FACSLYRIC¿

Additional Manufacturer Narrative

E.1. INITIAL REPORTER ADDRESS: (B)(6). 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 THE BD FACSLYRIC¿ CARRYOVER INVOLVING PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED BY THE CUSTOMER THAT "SAMPLE CARRYOVER AT END OF THE ACQUISITION".

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE BD FACSLYRIC¿ CARRYOVER INVOLVING PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED BY THE CUSTOMER THAT "SAMPLE CARRYOVER AT END OF THE ACQUISITION".

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF SAMPLE CARRYOVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: MANUFACTURING, DEFECT, AND COMPLAINT TRENDS WERE REVIEWED. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS NO PARTS WERE REPLACED. POTENTIAL CAUSE WAS DUE TO IMPROPER SIT FLUSHES BETWEEN SAMPLES, AND THE ISSUE WAS RESOLVED AFTER APPLICATIONS PROVIDED REMOTE SUPPORT AND INSTRUCTED THE CUSTOMER TO IMPLEMENT ADDITIONAL SIT FLUSHES FOLLOWING SAMPLE ACQUISITION. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE ANY PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.