BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿

    MDR report key: 21756073 · Received April 2, 2025

    Report

    Report Number
    3027394506-2025-00012
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 5, 2025
    Report Date
    June 26, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING CONTAMINATION AND CARRYOVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING CONTAMINATION AND CARRYOVER WAS DETERMINED TO BE LINKED TO A DEFECTIVE PUMP IN THE FLUIDIC SYSTEM. THE ISSUE WAS RESOLVED AFTER THE PART WAS REPLACED. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PMA/510K CODES ARE: K170974, K201814. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED AFTER USAGE OF BD FACSLYRIC¿ . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOKE WITH CUSTOMER AND THEY ARE GETTING LASER DELAY SETUP ERRORS DURING PQC. THEY HAVE COMPLETED A FEW LONG CLEANS IN THE LAST FEW WEEKS BECAUSE THEY ARE STILL HAVING SOME CARRYOVER ISSUES BETWEEN SAMPLES. SYSTEM HAS BEEN HAVING ISSUES WITH CARRYOVER, CLEANING THE SYSTEM CLEARS UP THE ISSUE BUT IT COMES BACK AFTER A FEW DAYS. NO RESULTS WERE USED IF CARRYOVER WAS PRESENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED AFTER USAGE OF BD FACSLYRIC¿ . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOKE WITH CUSTOMER AND THEY ARE GETTING LASER DELAY SETUP ERRORS DURING PQC. THEY HAVE COMPLETED A FEW LONG CLEANS IN THE LAST FEW WEEKS BECAUSE THEY ARE STILL HAVING SOME CARRYOVER ISSUES BETWEEN SAMPLES. SYSTEM HAS BEEN HAVING ISSUES WITH CARRYOVER, CLEANING THE SYSTEM CLEARS UP THE ISSUE BUT IT COMES BACK AFTER A FEW DAYS. NO RESULTS WERE USED IF CARRYOVER WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372642 BD FACSLYRIC¿ FLOW CYTOMETRIC REAGENTS AND ACCESS OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 00382906635181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown