BD FACSCANTO¿ II FLOW CYTOMETER

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B5 DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT DURING USE WITH BD FACSCANTO¿ II FLOW CYTOMETER A HIGHER CELL COUNT THAN WHAT WAS ACTUALLY PRESENT WAS REPORTED TO CLINICIAN. THE SAMPLE WAS RECOLLECTED THROUGH APHERESIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE COUNT DELIVERED WAS HIGHER THAN THEY EXPECTED. ADDITIONAL INFORMATION: THE PROBLEM WAS FOUND TO BE WITH THE INSTRUMENT (WHICH WAS REPORTED), NOT THE REAGENT AS ORIGINALLY THOUGHT AT TIME OF MDR SUBMISSION. H6: IMDRF ANNEX G: G07001. H6: INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING THE COUNT DELIVERED WAS HIGHER THAN EXPECTED WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: DEVICE HISTORY REVIEW (DHR); COMPLAINT HISTORY REVIEW; SERVICE HISTORY REVIEW. THE POTENTIAL CAUSE WAS DUE TO THE FLUIDICS FLOW RATE NEEDING TO BE ADJUSTED TO OPTIMAL LEVEL. THE ISSUE WAS RESOLVED AFTER RECALIBRATION OF THE FLOW RATE. 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. 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 DURING USE WITH BD FACSCANTO¿ II FLOW CYTOMETER A HIGHER CELL COUNT THAN WHAT WAS ACTUALLY PRESENT WAS REPORTED TO CLINICIAN. THE SAMPLE WAS RECOLLECTED THROUGH APHERESIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE COUNT DELIVERED WAS HIGHER THAN THEY EXPECTED. ADDITIONAL INFORMATION - THE PROBLEM WAS FOUND TO BE WITH THE INSTRUMENT (WHICH WAS REPORTED), NOT THE REAGENT AS ORIGINALLY THOUGHT AT TIME OF MDR SUBMISSION.

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 BD FACSCANTO¿ II FLOW CYTOMETER A HIGHER CELL COUNT THAN WHAT WAS ACTUALLY PRESENT WAS REPORTED TO CLINICIAN. THE SAMPLE WAS RECOLLECTED THROUGH APHERESIS. INFORMATION REGARDING THE CATALOG# AND LOT# OF THE BD¿ STEM CELL ENUMERATION KIT HAVE NOT YET BEEN OBTAINED. A SUPPLEMENTAL WILL BE SUBMITTED WHEN INFORMATION IS OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE COUNT DELIVERED WAS HIGHER THAN THEY EXPECTED ADDITIONAL INFORMATION OBTAINED ON 31JUL2025: THIS CASE WAS REPORTED AS A PRODUCT FAILURE, IT WAS IDENTIFIED LATER THAT THE PROBLEM STEMMED FROM INCORRECT USAGE OF THE KIT¿THEY WERE NOT FOLLOWING THE PROTOCOL AS OUTLINED IN THE INSTRUCTIONS FOR USE.... ADDITIONALLY, THE PROBLEM THAT OCCURRED INVOLVED THE QUANTIFICATION OF STEM CELLS USING THE BD¿ STEM CELL ENUMERATION KIT. THE LABORATORY REPORTED A SLIGHTLY HIGHER CELL COUNT THAN WHAT WAS ACTUALLY PRESENT. THIS INFORMATION WAS COMMUNICATED TO THE PHYSICIAN, AND CONSEQUENTLY, AN ADDITIONAL SAMPLE HAD TO BE COLLECTED FROM THE PATIENT THE FOLLOWING DAY IN ORDER TO PROCEED WITH THE TRANSPLANT.