BD FACSLYRIC¿
Received Jul 25, 2024 · Event occurred Jun 26, 2024
Report 2916837-2024-00042 · MDR key 19830877
Device
Generic name
Counter, Differential Cell
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
662878
Product problems
- Contamination of Device Ingredient or Reagent
- Contamination of Device Ingredient or Reagent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
G.5 PMA / 510(K)#: K170974, K201814 H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT SEEING PATIENTS CELL POPULATION WHEN RUN A TUBE WITH ONLY PBS AFTER THE PATIENT SAMPLE/BD FSE IS ONSITE ALREADY AND WORKING ON CROSSOVER ISSUE."
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT SEEING PATIENTS CELL POPULATION WHEN RUN A TUBE WITH ONLY PBS AFTER THE PATIENT SAMPLE/BD FSE IS ONSITE ALREADY AND WORKING ON CROSSOVER ISSUE."
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE CARRYOVER WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING : THE POTENTIAL CAUSE FOR THE CARRYOVER COULD NOT BE DETERMINED. THE CUSTOMER REPORTED A COMPLAINT REGARDING SEEING PATIENTS CELL POPULATION WHEN RUN A TUBE WITH ONLY PBS AFTER THE PATIENT SAMPLE. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A SERVICE VISIT. THEY VERIFIED THE SIT FLUSH, REPLACED SAMPLE LINE WITH PN 652754. AFTER THE WORKS PERFORMED, THE CUSTOMER REPEATED THE ASSAY AND CONFIRMED THAT CARRYOVER WAS NO LONGER PRESENT. THE INSTRUMENT WAS CONFIRMED TO BE PERFORMING ACCORDING TO SPECIFICATIONS. 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.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION. H.6 IMDRF ANNEX: B21. H.6 IMDRF ANNEX: C21. H.6 IMDRF ANNEX: D16.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT SEEING PATIENTS CELL POPULATION WHEN RUN A TUBE WITH ONLY PBS AFTER THE PATIENT SAMPLE/BD FSE IS ONSITE ALREADY AND WORKING ON CROSSOVER ISSUE."