BD FACSLYRIC¿ 3L10C INSTRUMENT

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES. REPORTING OFFICE CONTACT: FAHMY RAZAK - MDR. MANUFACTURING SITE CONTACT: FAHMY RAZAK - MDR. H.6: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF ¿ARM BOARD¿ ERROR MESSAGED SHOWING UP DURING SAMPLE RUNS WAS CONFIRMED. THE POTENTIAL CAUSE OF THE ISSUE WAS DETERMINED TO BE A DEFECTIVE LOADER/UAL. AFTER THE FSE REPLACED AND CALIBRATED THE UAL, REINSTALLED THE FIRMWARE, AND RAN TESTS, THE INSTRUMENT WAS FOUND TO BE WORKING AS EXPECTED. THE ISSUE WAS WITH THE UAL AND NOT THE LYRIC ITSELF, AND THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT. REVIEW OF THE DHR CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION. 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 BD FACSLYRIC¿ 3L10C INSTRUMENT AN "ARM BOARD" ERROR WAS BYPASSED WHILE RUNNING PATIENT SAMPLES. PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CX SAYS THEY ARE HAVING A PERSISTENT ""ARM BOARD"" ERROR WHERE IT IS PREVENTING RUNNING OF THEIR CLINICAL SAMPLES. 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST?(IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? ((IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ 3L10C INSTRUMENT AN "ARM BOARD" ERROR WAS BYPASSED WHILE RUNNING PATIENT SAMPLES. PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CX SAYS THEY ARE HAVING A PERSISTENT ""ARM BOARD"" ERROR WHERE IT IS PREVENTING RUNNING OF THEIR CLINICAL SAMPLES. 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST?(IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? ((IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES.

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.