BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿

    MDR report key: 19537791 · Received June 14, 2024

    Report

    Report Number
    2916837-2024-00036
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906635181
    PMA / PMN Number
    K201814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UNIQUE IDENTIFICATION NUMBER: (B)(4). H3. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE REGARDING CARRYOVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE POTENTIAL CAUSE FOR THE CARRYOVER WAS PARTIALLY CLOGGED SAMPLE LINE AND POOR SIT FLUSH ASPIRATION. THE CUSTOMER REPORTED AN ISSUE REGARDING THEIR SYSTEM HAVING CARRYOVER ISSUES. THEY NOTED THAT THE CARRYOVER ONLY HAPPENS WHEN RUNNING MANUALLY WITH TUBES. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A SERVICE VISIT. THEY REPLACED THE SAMPLE LINE AND FLUSHED OUT THE VALVE V8 PINCH VALVE TUBING USING BLEACH SOLUTION. THEY PERFORMED A SERIES OF CALIBRATION AND ALIGNMENT TO VERIFY FUNCTIONALITY. AFTER THE WORKS PERFORMED, THE INSTRUMENT WAS TESTED AND WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. 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.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: NA. E.1.: (B)(6). 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 · 0

    IT WAS REPORTED THAT CARRYOVER WAS OBSERVED IN PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? CARRYOVER BETWEEN PATIENT SAMPLES. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. SPOKE WITH CUSTOMER AND SHE TOLD ME THEY ARE HAVING ISSUES WITH CARRYOVER BETWEEN SAMPLES WHEN USING THE MANUAL MODE. THAT IS WHY THEY PLACED CALL. SYSTEM WILL NOT BE USED UNTIL SERVICED. SYSTEM IS HAVING CARRYOVER ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARRYOVER WAS OBSERVED IN PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE PATIENT SAMPLES CONTAMINATED OR WAS THEIR CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? CARRYOVER BETWEEN PATIENT SAMPLES PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST SPOKE WITH CUSTOMER AND SHE TOLD ME THEY ARE HAVING ISSUES WITH CARRYOVER BETWEEN SAMPLES WHEN USING THE MANUAL MODE. THAT IS WHY THEY PLACED CALL. SYSTEM WILL NOT BE USED UNTIL SERVICED. SYSTEM IS HAVING CARRYOVER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184006 BD FACSLYRIC¿ FLOW CYTOMETRIC REAGENTS AND ACCESS OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 00382906635181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown