BD FACS¿ LWA

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED:G.1. REPORTING OFFICE: (B)(6) G.2. REPORTING OFFICE CONTACT: (B)(6) G.4. MANUFACTURING SITE CONTACT: (B)(6) H.6. IMDRF ANNEX F GRID: F26 H.6.INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF EXCESSIVE CARRYOVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING:BASED ON THE INVESTIGATION REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE ACTIVITY REVIEW THE POTENTIAL CAUSE OF THE ISSUE WAS DETERMINED TO BE A FLUIDICS ISSUE. FSE REPLACED THE WASTE AND CLEANSE PUMPS, EXTERNAL TANKS TOWER AND CELL WASH TANK. FSE ALSO CHECKED TO ENSURE THAT THE FLUIDIC PATH TO SPINDLE CLEANSE TANK UP TO CELL WASH STATIONS IS UNCLOGGED. PER SUBSEQUENT TESTING, THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO PATIENTS WERE HARMED FROM ANY ERRONEOUS RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. 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. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD FACS¿ LWA CARRYOVER WAS OBSERVED ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS EXCESSIVE CARRYOVER. IS INSTRUMENT ASSURITY LINC ENABLED? NO. CUSTOMER PROBLEM: EXCESSIVE CARRYOVER. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THE CUSTOMER REPORTS THAT THEY ARE SEEING EXCESSIVE CARRYOVER FROM SAMPLE TO SAMPLE. THEY PERFORMED A CARRYOVER STUDY AND FOUND THE CARRYOVER AMOUNT TO BE 0.035%, 7 TIMES THE TECHNICAL SPECIFICATON OF =0.005%. THE INSTRUMENT HAS BEEN PLACED DOWN AND OUT OF SERVICE, NO ERRONEOUS RESULTS WERE REPORTED OUT AND NO PATIENTS WERE AFFECTED.  NEXT STEPS (IF NECESSARY): DISPATCHING. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO WAS THERE ANY INJURY OR POTENTIAL INJURY? NO RESOLUTION ACHIEVED? NO FOLLOW UP REQUIRED? NO SOFTWARE VERSION? NA LIST OF PARTS SHIPPED (INCLUDE FOC): NA RMA REQUIRED? NA CALL ACTIVITY COMMENT: ¿ CUSTOMER INQUIRY/PROBLEM: INCREASED CARRYOVER. WE NOTED CELLS FROM ANOTHER PATIENT CONTAMINATING A SPECIMEN'S RESULTS. WE PERFORMED A CARRYOVER STUDY AND FOUND A CARRYOVER OF 0.035%. THE TECHNICAL SPECS STAT THAT IT SHOULD BE =0.005%. ¿ STEPS TAKEN WITH CUSTOMER: RECEIVED VIA EMAIL, CREATED A CASE ¿ OUTCOME/RESOLUTION: PENDING CALL BACK BY TRAINED AGENT INCREASED CARRYOVER. CUSTOMER NOTED CELLS FROM ANOTHER PATIENT CONTAMINATING A SPECIMEN'S RESULTS. CUSTOMER PERFORMED A CARRYOVER STUDY AND FOUND A CARRYOVER OF 0.035%. THE TECHNICAL SPECS STATE THAT IT SHOULD BE =0.005%.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD FACS¿ LWA CARRYOVER WAS OBSERVED ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS EXCESSIVE CARRYOVER. IS INSTRUMENT ASSURITY LINC ENABLED? NO. CUSTOMER PROBLEM: EXCESSIVE CARRYOVER. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THE CUSTOMER REPORTS THAT THEY ARE SEEING EXCESSIVE CARRYOVER FROM SAMPLE TO SAMPLE. THEY PERFORMED A CARRYOVER STUDY AND FOUND THE CARRYOVER AMOUNT TO BE 0.035%, 7 TIMES THE TECHNICAL SPECIFICATION OF =0.005%. THE INSTRUMENT HAS BEEN PLACED DOWN AND OUT OF SERVICE, NO ERRONEOUS RESULTS WERE REPORTED OUT AND NO PATIENTS WERE AFFECTED.  NEXT STEPS (IF NECESSARY): DISPATCHING. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? NO. SOFTWARE VERSION? NA. LIST OF PARTS SHIPPED (INCLUDE FOC): NA. RMA REQUIRED? NA. CALL ACTIVITY COMMENT: CUSTOMER INQUIRY/PROBLEM: INCREASED CARRYOVER. WE NOTED CELLS FROM ANOTHER PATIENT CONTAMINATING A SPECIMEN'S RESULTS. WE PERFORMED A CARRYOVER STUDY AND FOUND A CARRYOVER OF 0.035%. THE TECHNICAL SPECS STAT THAT IT SHOULD BE =0.005%. STEPS TAKEN WITH CUSTOMER: RECEIVED VIA EMAIL, CREATED A CASE. OUTCOME/RESOLUTION: PENDING CALL BACK BY TRAINED AGENT. INCREASED CARRYOVER. CUSTOMER NOTED CELLS FROM ANOTHER PATIENT CONTAMINATING A SPECIMEN'S RESULTS. CUSTOMER PERFORMED A CARRYOVER STUDY AND FOUND A CARRYOVER OF 0.035%. THE TECHNICAL SPECS STATE THAT IT SHOULD BE =0.005%.

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.