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. E.1. INITIAL REPORTER ADDRESS: (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT CARRYOVER INVOLVING PATIENT SAMPLES WAS OBSERVED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAMPLE CARRYOVER AT END OF THE ACQUISITION. 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. CARRYOVER BETWEEN PATIENT SAMPLES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. CUSTOMER INFORMED THEY ARE HAVING SAMPLE CARRYOVER AT END OF THE ACQUISITION.

Description of Event or Problem

IT WAS REPORTED THAT CARRYOVER INVOLVING PATIENT SAMPLES WAS OBSERVED DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAMPLE CARRYOVER AT END OF THE ACQUISITION. 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. CARRYOVER BETWEEN PATIENT SAMPLES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. CUSTOMER INFORMED THEY ARE HAVING SAMPLE CARRYOVER AT END OF THE ACQUISITION.

Additional Manufacturer Narrative

THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX G: G07001. 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.