BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿ INSTRUMENT

    MDR report key: 21868586 · Received April 18, 2025

    Report

    Report Number
    3027394506-2025-00016
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 20, 2025
    Report Date
    May 16, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906628756
    PMA / PMN Number
    K201814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5. ADDITIONAL PMA / 510(K)#: BK230835, K170974, 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

    H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE CAUSE OF THE COMPLAINT WAS CONFIRMED TO BE DUE TO A DAMAGED WASTE TUBING. THE CUSTOMER INITIALLY REPORTED CARRYOVER OBSERVED ON THIS INSTRUMENT AND A BD FIELD SERVICE ENGINEER WAS SENT ONSITE TO ADDRESS THE ISSUE. THE FSE IDENTIFIED THAT THE ORANGE WASTE FITTING WAS DAMAGED AND TRIMMED OFF THE DAMAGED PORTION. THEY THEN REASSEMBLED THE SIT MOUNT, REINSTALLED ONTO THE INSTRUMENT, AND CONFIRMED THAT THE INSTRUMENT WAS FUNCTIONING AS EXPECTED PER BD SPECIFICATIONS. NO ONE WAS HARMED OR INJURED, AND THERE WAS NO IMPACT TO PATIENT DIAGNOSIS OR TREATMENT. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED WITHOUT REQUIRING A SAMPLE ANALYSIS. TWO OTHER COMPLAINTS WERE IDENTIFIED WITH CARRYOVER DUE TO DAMAGED TUBING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A BD FACSLYRIC¿ INSTRUMENT CARRYOVER OCCURRED AND A FALSE POSITIVE RESULT WAS OBTAINED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE GETTING CARRY OVER FROM ONE SAMPLE TO THE NEXT. IF THE FIRST SAMPLE IS POSITIVE AND THE SECOND SAMPLE IS TO BE NEGATIVE, IT IS COMING UP POSITIVE FROM CELL INFILTRATES FROM THE POSITIVE FIRST TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A BD FACSLYRIC¿ INSTRUMENT CARRYOVER OCCURRED AND A FALSE POSITIVE RESULT WAS OBTAINED ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE GETTING CARRY OVER FROM ONE SAMPLE TO THE NEXT. IF THE FIRST SAMPLE IS POSITIVE AND THE SECOND SAMPLE IS TO BE NEGATIVE, IT IS COMING UP POSITIVE FROM CELL INFILTRATES FROM THE POSITIVE FIRST TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776446 BD FACSLYRIC¿ INSTRUMENT FLOW CYTOMETRIC REAGENTS AND ACCESS OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 00382906628756

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown