BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿ FLOW CYTOMETER

    MDR report key: 22399344 · Received July 3, 2025

    Report

    Report Number
    3027394506-2025-00031
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 17, 2025
    Report Date
    September 8, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906635181
    PMA / PMN Number
    BK230835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). E.1. INITIAL REPORTER FACILITY NAME: (B)(6). G.5. PMA / 510(K) ADDITIONAL #170974; 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

    H.6: INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE LARGE SAMPLE RESIDUE WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: DEVICE HISTORY REVIEW (DHR), COMPLAINT HISTORY REVIEW, AND SERVICE HISTORY REVIEW. THE POTENTIAL CAUSE FOR THE LARGE SAMPLE RESIDUE WAS FAULTY PUMP AND DEGASSER. THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE FAULTY PARTS. AFTER THE REPLACEMENT, THE INSTRUMENT WAS TESTED AND WAS CONFIRMED TO BE PERFORMING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER INVOLVING PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: LARGE SAMPLE RESIDUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER INVOLVING PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: LARGE SAMPLE RESIDUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856231 BD FACSLYRIC¿ FLOW CYTOMETER FLOW CYTOMETRIC REAGENTS AND ACCESSORIES OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 00382906635181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown