BD FACSLYRIC¿
Received Jun 6, 2025 · Event occurred May 22, 2025
Report 3027394506-2025-00025 · MDR key 22159597
Device
Generic name
Flow Cytometric Reagents And Access
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
663029
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ A REBOOT OCCURRED AND CARRYOVER BETWEEN PATIENT SAMPLE OCCURRED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A CUSTOMER REPORTS THAT THE ISSUE WITH QUERY 02743635 PERSISTS AGAIN DURING A STUDY ON PATIENT SAMPLES. ACCORDING TO THE CUSTOMER, A COLD REBOOT WAS PERFORMED, WHICH UNLOCKED THE INSTRUMENT, BUT CONTAMINATION WAS DETECTED IN THE RESULTS. ACCORDING TO THE CUSTOMER, THEY PERFORMED A NEW STUDY ON THE SAMPLES, THIS TIME WITHOUT CONTAMINATION.
Additional Manufacturer Narrative
H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX G: G07001. H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF INTERMITTENT ISSUES OR POTENTIAL CARRYOVER WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: O MANUFACTURING, DEFECT, AND COMPLAINT TRENDS WERE REVIEWED O A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE DEFECTIVE PART WAS DISCARDED. O POTENTIAL CAUSE COULD NOT BE REPLICATED IS UNKNOWN. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BY THE SERVICE ENGINEER WITH CLEANING OF THE LOADER, REINSTALLATION OF THE LOADER FIRMWARE, AND CALIBRATION BEFORE ANY PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ A REBOOT OCCURRED AND CARRYOVER BETWEEN PATIENT SAMPLE OCCURRED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A CUSTOMER REPORTS THAT THE ISSUE WITH QUERY (B(6) PERSISTS AGAIN DURING A STUDY ON PATIENT SAMPLES. ACCORDING TO THE CUSTOMER, A COLD REBOOT WAS PERFORMED, WHICH UNLOCKED THE INSTRUMENT, BUT CONTAMINATION WAS DETECTED IN THE RESULTS. ACCORDING TO THE CUSTOMER, THEY PERFORMED A NEW STUDY ON THE SAMPLES, THIS TIME WITHOUT CONTAMINATION.