BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ LYSE WASH ASSISTANT

    MDR report key: 22399346 · Received July 3, 2025

    Report

    Report Number
    3027394506-2025-00032
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 4, 2025
    Report Date
    August 6, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    UDI-DI
    00382903371464
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELD WAS UPDATED WITH CORRECTED INFORMATION: H.6 ANNEX G CODE: G04069 H.6 INVESTIGATION SUMMARY: INVESTIGATION EXECUTIVE SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING HIGH BACKGROUND ON LYMPHOMA PANELS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: -THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. -REVIEW OF THE DEVICE HISTORY RECORD (DHR). -CONDUCTED SYSTEM CALIBRATION AND TESTING THE POTENTIAL CAUSE OF HIGH BACKGROUND ON LYMPHOMA PANELS WAS DUE TO CLOGGED AND DIRTY FLUIDIC LINES WHERE TUBING AND CONNECTORS NEEDED TO BE REPLACED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT CONTAMINATED LINES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM GETTING HIGH BACKGROUND ON ALL OF MY LEUKEMIA AND LYMPHOMA PANELS. I HAVE ISOLATED IT TO SOMETHING ON THE LWA. THE ISSUE ONLY HAPPENS WHEN I RUN ON THE LWA. IF I DO A MANUAL PROCEDURE EVERYTHING WORKS FINE. PATIENT SAMPLES CONTAMINATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACS¿ LYSE WASH ASSISTANT CONTAMINATED LINES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM GETTING HIGH BACKGROUND ON ALL OF MY LEUKEMIA AND LYMPHOMA PANELS. I HAVE ISOLATED IT TO SOMETHING ON THE LWA. THE ISSUE ONLY HAPPENS WHEN I RUN ON THE LWA. IF I DO A MANUAL PROCEDURE EVERYTHING WORKS FINE. PATIENT SAMPLES CONTAMINATED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856233 BD FACS¿ LYSE WASH ASSISTANT STATION, PIPETTING DILUTING CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 00382903371464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown