BD FACSLYRIC¿
Received Oct 8, 2024 · Event occurred Sep 6, 2024
Report 2916837-2024-00048 · MDR key 20397462
Device
Generic name
Flow Cytometric Reagents And Accessories
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
651164
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
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¿ ERRONEOUS RESULTS WERE OBTAINED AND REPORTED OUT TO A CLINICIAN. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STRONG DISCREPANCY IN TOTAL WHITE COUNT AND ALTHOUGH PQC PASSES WITH GOOD RESULT I NOTICED A LOSS OF FLUORESCENCE COMPARED TO A SAMPLE ACQUIRED IN (B)(6)."
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION, THE REPORTED ISSUE OF STRONG DISCREPANCY IN THE DATA ALTHOUGH THE QC CHECK PASSED WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: -THE POTENTIAL CAUSE WAS DETERMINED TO BE USER ERROR. -THE FSE RE-RAN COMPENSATION CALIBRATION, AND THE ACQUIRED SAMPLES WERE WITHIN SPECIFICATION, AND THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. -NO ONE WAS HARMED OR INJURED, AND NO PATIENTS WERE HARMED FROM ANY ERRONEOUS RESULTS. -THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. COMPLAINTS RECEIVED FOR THIS DEVICE WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED TO DETERMINE IF FURTHER ACTION IS NEEDED. 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 WHILE USING BD FACSLYRIC¿ ERRONEOUS RESULTS WERE OBTAINED AND REPORTED OUT TO A CLINICIAN. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STRONG DISCREPANCY IN TOTAL WHITE COUNT AND ALTHOUGH PQC PASSES WITH GOOD RESULT I NOTICED A LOSS OF FLUORESCENCE COMPARED TO A SAMPLE ACQUIRED IN JUNE.".