BD FACS¿ LYSE WASH ASSISTANT

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION. DATE RECEIVED BY MANUFACTURER WAS CHANGED FROM 11/15/2023 TO 10/12/2023.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT ERRONEOUS RESULTS OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PROBLEM IS CD45 EVENTS THAT ARE SEEN AFTER PREPARATION IN LWA BUT NOT DURING MANUAL PREP. WE HAVE DEBUGGED WITH VARIOUS SAMPLE MATERIALS, FOR PERIPHERAL BLOOD THE PROBLEM IS NOT SO VISIBLE, ON THE OTHER HAND FOR BONE MARROW AND E.G. BRONCHOALVEOLAR LAVAGE" 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): UNKNOWN. 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 #5. IF NO, NO FURTHER QUESTIONS REQUIRED): UNKNOWN. 5.PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6): FURTHER DETAILS ON PATIENT IMPACT HAVE BEEN REQUESTED TO CUSTOMER.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT ERRONEOUS RESULTS OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PROBLEM IS CD45 EVENTS THAT ARE SEEN AFTER PREPARATION IN LWA BUT NOT DURING MANUAL PREP. WE HAVE DEBUGGED WITH VARIOUS SAMPLE MATERIALS, FOR PERIPHERAL BLOOD THE PROBLEM IS NOT SO VISIBLE, ON THE OTHER HAND FOR BONE MARROW AND E.G. BRONCHOALVEOLAR LAVAGE" 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): UNKNOWN 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 #5. IF NO, NO FURTHER QUESTIONS REQUIRED): UNKNOWN 5.PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6): FURTHER DETAILS ON PATIENT IMPACT HAVE BEEN REQUESTED TO CUSTOMER.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE CONTACT - (B)(6). G.1 - MANUFACTURING SITE CONTACT - (B)(6). G.1 - REPORTING OFFICE- BECTON DICKINSON AND COMPANY BD BIOSCIENCES. H.6 - IMDRF ANNEX F CODE- F26. H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR UNEXPECTED POPULATIONS WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE DHR WAS REVIEWED TO ENSURE THAT THE INSTRUMENT MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. AN APPLICATION SPECIALISTS TRIED TO IDENTIFY THE CAUSE AND COULD NOT REPLICATE THE ISSUE NOR DETERMINE THE PROBLEM AS THE INSTRUMENT WAS PERFORMING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. 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 FACS¿ LYSE WASH ASSISTANT ERRONEOUS RESULTS OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PROBLEM IS CD45 EVENTS THAT ARE SEEN AFTER PREPARATION IN LWA BUT NOT DURING MANUAL PREP. WE HAVE DEBUGGED WITH VARIOUS SAMPLE MATERIALS, FOR PERIPHERAL BLOOD THE PROBLEM IS NOT SO VISIBLE, ON THE OTHER HAND FOR BONE MARROW AND E.G. BRONCHOALVEOLAR LAVAGE". 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): UNKNOWN. 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 #5. IF NO, NO FURTHER QUESTIONS REQUIRED): UNKNOWN. 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6): FURTHER DETAILS ON PATIENT IMPACT HAVE BEEN REQUESTED TO CUSTOMER.