BD FACSVIA¿ FLOW CYTOMETER

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 ERRONEOUS RESULTS WERE OBTAINED ON PATIENT SAMPLES DURING USE WITH THE BD FACSVIA¿ FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, 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) NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED) NO. 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6). 6. WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTIONS REQUIRED.). FSE IS REPORTING A CASE OF LOW CD4 RESULTS.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: PATIENT ANNEX CODE WAS CORRECTED TO F26. REPORTING OFFICE: BECTON DICKINSON AND COMPANY BD BIOSCIENCES. REPORTING OFFICE CONTACT: FAHMY RAZAK - MDR. MANUFACTURING SITE CONTACT: FAHMY RAZAK - MDR. BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE UNEXPECTED LOW CD4 RESULTS COULD NOT BE CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: DHR WAS REVIEWED TO ENSURE THAT THE INSTRUMENT MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE POTENTIAL CAUSE COULD NOT BE CONFIRMED. THE CUSTOMER REPORTED A COMPLAINT REGARDING A CASE OF LOW CD4 RESULTS. THEY WERE USING EXPIRED BEADS AT THE TIME OF THE REPORT. THE INSTRUMENT QC WAS SUCCESSFUL. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS IDENTIFIED AND 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 ERRONEOUS RESULTS WERE OBTAINED ON PATIENT SAMPLES DURING USE WITH THE BD FACSVIA¿ FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, 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) NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED) NO. 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6). 6. WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTIONS REQUIRED.) FSE IS REPORTING A CASE OF LOW CD4 RESULTS.