BD FACSLYRIC¿
Received Jan 12, 2024 · Event occurred Oct 9, 2023
Report 2916837-2023-00238 · MDR key 18507602
Device
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
D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ ERRONEOUS RESULTS WERE OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SINCE OCTOBER, THE ABSOLUTE COUNT (ASSAYS IN FACSUITE CLINICAL) ARE TOO HIGH. THIS HAPPENED WITH 2 DIFFERENT LOTS OF MULTICHECK AND WITH 2 DIFFERENT TRUCOUNT LOTS (23128 AND 23261). THE PQC SHOWS A SLIGHT TREND UPWARDS (9-10V) FOR FSC/SSC MAINLY. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ ERRONEOUS RESULTS WERE OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SINCE OCTOBER, THE ABSOLUTE COUNT (ASSAYS IN FACSUITE CLINICAL) ARE TOO HIGH. THIS HAPPENED WITH 2 DIFFERENT LOTS OF MULTICHECK AND WITH 2 DIFFERENT TRUCOUNT LOTS (23128 AND 23261) THE PQC SHOWS A SLIGHT TREND UPWARDS (9-10V) FOR FSC/SSC MAINLY. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE CONTACT - (B)(6) G.1 - MANUFACTURING SITE CONTACT - (B)(6) H.6 INVESTIGATION SUMMARY: BASED ON THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICE ACTIVITY REVIEW, THE COMPLAINT WAS CONFIRMED, AND THE POTENTIAL CAUSE OF THE UNEXPECTED RESULTS WAS DETERMINED TO BE LOW POWER OF THE BLUE LASER. THE FSE REPLACED THE BLUE LASER, AND SUBSEQUENT TESTING SHOWED THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO PATIENTS WERE DIAGNOSED OR TREATED BASED ON 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 ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10