BD FACS¿ LYSE WASH ASSISTANT

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 DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT, CARRYOVER WAS OBSERVED IN PATIENT SAMPLES. NO PATIENT IMPACT WAS IDENTIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE SUSPECT CARRY OVER BETWEEN SAMPLES IN THE LWA. WE HAVE EXPERIENCED ¿UNEXPECTED¿ SICK CELLS IN TWO DIFFERENT SAMPLES ON TWO DIFFERENT DAYS. ONCE WE REPEAT THE SAMPLES WE NO LONGER SEE THE ¿UNEXPECTED¿ CELLS. IN BOTH SAMPLES THE PREPARATION WAS PERFORMED ON THE LWA AND IN BOTH CASES OTHER SAMPLES WERE PROCESSED (WASHED AND LYSED) IN A ROW IN CAROUSEL IN THE LWA.IT WAS ALSO COMMON BETWEEN THE TWO SAMPLES WITH ¿UNEXPECTED¿ CELLS THAT THE SAMPLE JUST BEFORE IN THE ROW IN LWA CONTAINED HIGH NUMBER OF SICK CELLS. THE IMMUNOPROFILE OF THE SICK CELLS CORRESPOND TO THE ¿UNEXPECTED¿ CELLS. WE THEREFORE TESTED THE HYPOTHESIS OF CARRY OVER. WE DO SEE CARRY OVER OF SICK UNEXPECTED CELLS BETWEEN SAMPLES. IN THIS CASE WE HAD PLACED FOUR TUBES IN THE LWA: SICK ¿ HEALTHY ¿ SICK- HEALTHY WE WASHED AND LYSED THE SAMPLES ACCORDING TO THE SCHEDULE BELOW: TEST 1: WE OBSERVED 26 SICK CELLS OUT OF A TOTAL OF 99.414 CELLS = CARRY OVER OF 0,03% TEST 2: WE OBSERVE 39 SICK CELLS OUT OF TOTAL OF 100.630 CELLS= CARRY OVER OF 0,04 % ACCORDING TO THE TECH SPECS THE EXPECTED CARRY OVER IS 0,005%

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT, CARRYOVER WAS OBSERVED IN PATIENT SAMPLES. NO PATIENT IMPACT WAS IDENTIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE SUSPECT CARRY OVER BETWEEN SAMPLES IN THE LWA. WE HAVE EXPERIENCED ¿UNEXPECTED¿ SICK CELLS IN TWO DIFFERENT SAMPLES ON TWO DIFFERENT DAYS. ONCE WE REPEAT THE SAMPLES WE NO LONGER SEE THE ¿UNEXPECTED¿ CELLS. IN BOTH SAMPLES THE PREPARATION WAS PERFORMED ON THE LWA AND IN BOTH CASES OTHER SAMPLES WERE PROCESSED (WASHED AND LYSED) IN A ROW IN CAROUSEL IN THE LWA.IT WAS ALSO COMMON BETWEEN THE TWO SAMPLES WITH ¿UNEXPECTED¿ CELLS THAT THE SAMPLE JUST BEFORE IN THE ROW IN LWA CONTAINED HIGH NUMBER OF SICK CELLS. THE IMMUNOPROFILE OF THE SICK CELLS CORRESPOND TO THE ¿UNEXPECTED¿ CELLS. WE THEREFORE TESTED THE HYPOTHESIS OF CARRY OVER. WE DO SEE CARRY OVER OF SICK UNEXPECTED CELLS BETWEEN SAMPLES. IN THIS CASE WE HAD PLACED FOUR TUBES IN THE LWA: SICK ¿ HEALTHY ¿ SICK- HEALTHY. WE WASHED AND LYSED THE SAMPLES ACCORDING TO THE SCHEDULE BELOW: TEST 1: WE OBSERVED 26 SICK CELLS OUT OF A TOTAL OF 99.414 CELLS = CARRY OVER OF 0,03% TEST 2: WE OBSERVE 39 SICK CELLS OUT OF TOTAL OF 100.630 CELLS= CARRY OVER OF 0,04 % ACCORDING TO THE TECH SPECS THE EXPECTED CARRY OVER IS 0,005%

Additional Manufacturer Narrative

THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX A CODE - A1801. H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING CARRYOVER FOR PATIENT ID: (B)(6) OCCURRING ON (B)(6) 2025 WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING CARRYOVER DUE TO THE CELL WASH ASSEMBLY. THE ISSUE WAS RESOLVED AFTER THE FLUSHING BLOCK IN THE CELL WASH ASSEMBLY WAS ADJUSTED AND A LONG CLEAN WAS PERFORMED. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING 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.