inforMED
MalfunctionOYE

BD FACSLYRIC¿

Received Nov 3, 2023 · Event occurred Aug 9, 2023

Report 2916837-2023-00213 · MDR key 18066338

Device

Generic name

Flow Cytometric Reagents And Accessories

Catalog number

662875

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

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE (B)(6). G.1 - MANUFACTURING SITE CONTACT - (B)(4). H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE COMPLAINT WAS CONFIRMED AND THE POTENTIAL CAUSE OF THE CUSTOMER EXPERIENCING ERRONEOUS RESULTS ON THE FACSLYRIC WAS DETERMINED TO BE A WORN-OUT PIPETTE. THE CUSTOMER REPLACED THE PIPETTE DURING TROUBLESHOOTING AND THE INSTRUMENT IS FUNCTIONING AS EXPECTED. CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT IMPACT. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. 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 AFTER USING BD FACSLYRIC¿ ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT ABSOLUTE VALUES TRENDING HIGH FOR CD3,CD8,CD45 TRUCOUNT ASSAY. CX SAYS THE ABSOLUTE NUMBERS ARE TOO HIGH FOR THE IVD CD3,CD8,CD45 TRUCOUNT ASSAY. CX HAS TRIED A NEW LOT OF CSANDT BEADS AND TRIED GOING BACK TO THE OLD CSANDT BEAD LOT AND FINDS THE ABSOLUTE NUMBERS FOR THIS TEST IS STILL TRENDING UPWARD. CX HAS BEEN USING CALIBRATED PIPETTES AND ALSO TRYING REVERSE PIPETTE TECHNIQUES. CX USES THIS INSTRUMENT FOR CLINICAL SAMPLES BUT THE TRENDS WERE NOTICED ON NORMAL CONTROLS. CX SAYS THIS ISSUE MAY OF IMPACTED SOME CLINICAL SAMPLES. ABSOLUTE VALUES TRENDING HIGH FOR CD3,CD8,CD45 TRUCOUNT ASSAY.

Description of Event or Problem

IT WAS REPORTED THAT AFTER USING BD FACSLYRIC¿ ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT ABSOLUTE VALUES TRENDING HIGH FOR CD3,CD8,CD45 TRUCOUNT ASSAY. CX SAYS THE ABSOLUTE NUMBERS ARE TOO HIGH FOR THE IVD CD3,CD8,CD45 TRUCOUNT ASSAY. CX HAS TRIED A NEW LOT OF CSANDT BEADS AND TRIED GOING BACK TO THE OLD CSANDT BEAD LOT AND FINDS THE ABSOLUTE NUMBERS FOR THIS TEST IS STILL TRENDING UPWARD. CX HAS BEEN USING CALIBRATED PIPETTES AND ALSO TRYING REVERSE PIPETTE TECHNIQUES. CX USES THIS INSTRUMENT FOR CLINICAL SAMPLES BUT THE TRENDS WERE NOTICED ON NORMAL CONTROLS. CX SAYS THIS ISSUE MAY OF IMPACTED SOME CLINICAL SAMPLES. ABSOLUTE VALUES TRENDING HIGH FOR CD3,CD8,CD45 TRUCOUNT ASSAY.

Additional Manufacturer Narrative

G.7: MULTIPLE PMA/510K# : K201814. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.