BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿

    MDR report key: 19830877 · Received July 25, 2024

    Report

    Report Number
    2916837-2024-00042
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 26, 2024
    Report Date
    September 20, 2024
    Manufacturer
    BECTON DICKINSON AND COMPANY BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906628787
    PMA / PMN Number
    BK230835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5 PMA / 510(K)#: K170974, K201814 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 · 0

    INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE CARRYOVER WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING : THE POTENTIAL CAUSE FOR THE CARRYOVER COULD NOT BE DETERMINED. THE CUSTOMER REPORTED A COMPLAINT REGARDING SEEING PATIENTS CELL POPULATION WHEN RUN A TUBE WITH ONLY PBS AFTER THE PATIENT SAMPLE. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A SERVICE VISIT. THEY VERIFIED THE SIT FLUSH, REPLACED SAMPLE LINE WITH PN 652754. AFTER THE WORKS PERFORMED, THE CUSTOMER REPEATED THE ASSAY AND CONFIRMED THAT CARRYOVER WAS NO LONGER PRESENT. THE INSTRUMENT WAS CONFIRMED TO BE PERFORMING ACCORDING TO SPECIFICATIONS. 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION. H.6 IMDRF ANNEX: B21. H.6 IMDRF ANNEX: C21. H.6 IMDRF ANNEX: D16.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT SEEING PATIENTS CELL POPULATION WHEN RUN A TUBE WITH ONLY PBS AFTER THE PATIENT SAMPLE/BD FSE IS ONSITE ALREADY AND WORKING ON CROSSOVER ISSUE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT SEEING PATIENTS CELL POPULATION WHEN RUN A TUBE WITH ONLY PBS AFTER THE PATIENT SAMPLE/BD FSE IS ONSITE ALREADY AND WORKING ON CROSSOVER ISSUE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OCCURRED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT SEEING PATIENTS CELL POPULATION WHEN RUN A TUBE WITH ONLY PBS AFTER THE PATIENT SAMPLE/BD FSE IS ONSITE ALREADY AND WORKING ON CROSSOVER ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229914 BD FACSLYRIC¿ COUNTER, DIFFERENTIAL CELL OYE BECTON DICKINSON AND COMPANY BD BIOSCIENCES 00382906628787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown