BD FACSCANTO¿

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE CONTACT - (B)(4). G.1 - MANUFACTURING SITE CONTACT - (B)(4). G.1 - REPORTING OFFICE- BECTON DICKINSON AND COMPANY BD BIOSCIENCES. H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE ISSUE WITH INCORRECT POPULATIONS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING : THE POTENTIAL CAUSE OF INCORRECT POPULATIONS WAS A DEFECTIVE AIR BUBBLE FILTER AND VALVE. THE DHR WAS REVIEWED TO CONFIRM THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A FIELD VISIT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A SERIES OF TROUBLESHOOTING WORKS AND REPLACED THE AIR BUBBLE FILTER, VALVE 6 AND BAL SEAL. AFTER THE WORKS PERFORMED, THE INSTRUMENT WAS TESTED AND CONFIRMED TO BE PERFORMING ACCORDING TO THE INSTRUMENT SPECIFICATIONS. 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 WHILE USING BD FACSCANTO¿, ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT POPULATIONS ARE NOT CORRECT. PATIENT SAMPLES CHECKLIST SUMMARY: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NOT APPLICABLE. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION # NO. 5. IF NO, NO FURTHER QUESTIONS REQUIRED): 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6): CONTAMINATION: 1.WERE SAMPLES CONTAMINATED?(IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES, OR UNKNOWN GO TO PATIENT SAMPLE CHECKLIST): NO. YES. LEAK CHECKLIST SUMMARY: 1. DID ANY LIQUID LEAKAGE OR SPLASH OR SPRAY COME INTO CONTACT WITH EYES OR MOUTH OR ANY MUCOUS MEMBRANE OR NON-INTACT(BROKEN) SKIN? IF NO, STOP- NO FURTHER QUESTIONS REQUIRED: NO.

Additional Manufacturer Narrative

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 WHILE USING BD FACSCANTO¿, ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT POPULATIONS ARE NOT CORRECT. PATIENT SAMPLES CHECKLIST SUMMARY: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): -YES 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): -NO 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): -NOT APPLICABLE 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION # -NO 5. IF NO, NO FURTHER QUESTIONS REQUIRED): 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6): CONTAMINATION: 1.WERE SAMPLES CONTAMINATED?(IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES, OR UNKNOWN GO TO PATIENT SAMPLE CHECKLIST): NO YES LEAK CHECKLIST SUMMARY: 1. DID ANY LIQUID LEAKAGE OR SPLASH OR SPRAY COME INTO CONTACT WITH EYES OR MOUTH OR ANY MUCOUS MEMBRANE OR NON-INTACT(BROKEN) SKIN? IF NO, STOP- NO FURTHER QUESTIONS REQUIRED: NO.