BD FACSLYRIC¿ INSTRUMENT
Received Apr 18, 2025 · Event occurred Mar 20, 2025
Report 3027394506-2025-00016 · MDR key 21868586
Device
Generic name
Flow Cytometric Reagents And Access
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
662875
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE CAUSE OF THE COMPLAINT WAS CONFIRMED TO BE DUE TO A DAMAGED WASTE TUBING. THE CUSTOMER INITIALLY REPORTED CARRYOVER OBSERVED ON THIS INSTRUMENT AND A BD FIELD SERVICE ENGINEER WAS SENT ONSITE TO ADDRESS THE ISSUE. THE FSE IDENTIFIED THAT THE ORANGE WASTE FITTING WAS DAMAGED AND TRIMMED OFF THE DAMAGED PORTION. THEY THEN REASSEMBLED THE SIT MOUNT, REINSTALLED ONTO THE INSTRUMENT, AND CONFIRMED THAT THE INSTRUMENT WAS FUNCTIONING AS EXPECTED PER BD SPECIFICATIONS. NO ONE WAS HARMED OR INJURED, AND THERE WAS NO IMPACT TO PATIENT DIAGNOSIS OR TREATMENT. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED WITHOUT REQUIRING A SAMPLE ANALYSIS. TWO OTHER COMPLAINTS WERE IDENTIFIED WITH CARRYOVER DUE TO DAMAGED TUBING.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH A BD FACSLYRIC¿ INSTRUMENT CARRYOVER OCCURRED AND A FALSE POSITIVE RESULT WAS OBTAINED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE GETTING CARRY OVER FROM ONE SAMPLE TO THE NEXT. IF THE FIRST SAMPLE IS POSITIVE AND THE SECOND SAMPLE IS TO BE NEGATIVE, IT IS COMING UP POSITIVE FROM CELL INFILTRATES FROM THE POSITIVE FIRST TUBE.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH A BD FACSLYRIC¿ INSTRUMENT CARRYOVER OCCURRED AND A FALSE POSITIVE RESULT WAS OBTAINED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE GETTING CARRY OVER FROM ONE SAMPLE TO THE NEXT. IF THE FIRST SAMPLE IS POSITIVE AND THE SECOND SAMPLE IS TO BE NEGATIVE, IT IS COMING UP POSITIVE FROM CELL INFILTRATES FROM THE POSITIVE FIRST TUBE.
Additional Manufacturer Narrative
G.5. ADDITIONAL PMA / 510(K)#: BK230835, K170974, H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.