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.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD FACSLYRIC¿, MANUALLY ENTERED CUSTOMER INFORMATION LED TO DIAGNOSTIC RESULTS BEING GENERATED FOR THE WRONG PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT LOOKS LIKE THE LYRICS AREN'T SCANNING THE BARCODES IN THE LOADER TO VERIFY THE WORKLIST - WE'VE REASON TO BELIEVE A WORKLIST WAS LOADED INCORRECTLY, BUT NO ALERT WAS GIVEN.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF ERRONEOUS RESULTS DUE TO BARCODE LABEL ISSUES WAS CONFIRMED. THE POTENTIAL CAUSE OF THE ISSUE WAS DETERMINED TO BE A USER WORKFLOW ISSUE. THE FSE INVESTIGATED THE ISSUE AND CONFIRMED THAT THE INSTRUMENT ITSELF WAS FUNCTIONING AS EXPECTED AND PROVIDED RECOMMENDATIONS FOR MORE SUITABLE BARCODE LABELS AND BETTER WORKFLOW STEPS. NO ONE WAS HARMED OR INJURED, AND THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT. REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS NO PARTS WERE REPLACED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD FACSLYRIC¿, MANUALLY ENTERED CUSTOMER INFORMATION LED TO DIAGNOSTIC RESULTS BEING GENERATED FOR THE WRONG PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT LOOKS LIKE THE LYRICS AREN'T SCANNING THE BARCODES IN THE LOADER TO VERIFY THE WORKLIST - WE'VE REASON TO BELIEVE A WORKLIST WAS LOADED INCORRECTLY, BUT NO ALERT WAS GIVEN.