BD FACSLYRIC¿ FLOW CYTOMETER
Received Apr 26, 2024 · Event occurred Apr 8, 2024
Report 2916837-2024-00028 · MDR key 19192684
Device
Generic name
Flow Cytometric Reagents And Access
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
663518
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF CARRYOVER WAS CONFIRMED. THE POTENTIAL CAUSE WAS DETERMINED TO BE FLUIDICS TUBING AND P1 PUMP FAILURES. THE FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE ISSUE AND REPLACED THE FLUIDICS TUBING AND THE P1 PUMP AND ITS FITTING, WHICH RESOLVED THE ISSUE AND RETURNED THE INSTRUMENT TO OPERATIONAL STATUS. THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT AND NO USER OR PATIENT WAS HARMED OR INJURED. THE COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE THE COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THEY ARE SEEING TRUCOUNT BEADS CARRYING OVER INTO SUBSEQUENT SAMPLES INTERMITTENTLY. ALSO, THEIR ABSOLUTE COUNTS WHEN RUN ON MULTIPLE TUBES ARE OFF. DID CARRYOVER HAPPENED ON PATIENT SAMPLES? "YES" THEY ARE SEEING TRUCOUNT BEAD CARRY OVER IN PATIENT SAMPLES.
Additional Manufacturer Narrative
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 DURING USE WITH BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THEY ARE SEEING TRUCOUNT BEADS CARRYING OVER INTO SUBSEQUENT SAMPLES INTERMITTENTLY. ALSO, THEIR ABSOLUTE COUNTS WHEN RUN ON MULTIPLE TUBES ARE OFF. DID CARRYOVER HAPPENED ON PATIENT SAMPLES? "YES" THEY ARE SEEING TRUCOUNT BEAD CARRY OVER IN PATIENT SAMPLES.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THEY ARE SEEING TRUCOUNT BEADS CARRYING OVER INTO SUBSEQUENT SAMPLES INTERMITTENTLY. ALSO, THEIR ABSOLUTE COUNTS WHEN RUN ON MULTIPLE TUBES ARE OFF. DID CARRYOVER HAPPENED ON PATIENT SAMPLES? "YES" THEY ARE SEEING TRUCOUNT BEAD CARRY OVER IN PATIENT SAMPLES.
Additional Manufacturer Narrative
THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX B: B21. H.6 IMDRF ANNEX C: C21. H.6 IMDRF ANNEX D: D16.