BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    MDR report key: 21719506 · Received March 28, 2025

    Report

    Report Number
    3027394506-2025-00010
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 8, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382903389629
    PMA / PMN Number
    K141468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5. ADDITIONAL PMA / 510(K)#: K040026, K040725, K050191, K062087. 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 OF QC FAILURE WHICH CAUSED ERRONEOUS RESULTS WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: COMPLAINT HISTORY REVIEW: THE POTENTIAL CAUSE WAS DUE TO THE USE OF EXPIRED BEADS. THE FIELD SERVICE ENGINEER (FSE) ALSO CONFIRMED THAT ALTHOUGH THE LOT NUMBER WAS CORRECT THE TARGET VOLTAGES WERE ALL SET TO DEFAULT AND THE SPECTRAL OVERLAPS WERE ALSO SET TO 100. THE FSE INPUTTED THE CORRECT VALUES AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS AN INCORRECT RESULT WAS REPORTED OUT TO A PHYSICIAN. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY DECIDED TO RUN THE SAMPLES AFTER THE PASS WITH THE EXPIRED BEADS. THEY SHOULD NOT HAVE REPORTED THE RESULTS BECAUSE OF THE EXPIRED 7 COLOR SET UP BEADS, AND UNFORTUNATELY THE RESULTS WERE USED FOR INCLUSION/EXCLUSION IN A STUDY. CUSTOMER CONFIRMED THAT THERE WAS NO HARM, NEGATIVE IMPACT, OR INJURY TO THE PATIENT AS FAR AS THEY KNOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS AN INCORRECT RESULT WAS REPORTED OUT TO A PHYSICIAN. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY DECIDED TO RUN THE SAMPLES AFTER THE PASS WITH THE EXPIRED BEADS. THEY SHOULD NOT HAVE REPORTED THE RESULTS BECAUSE OF THE EXPIRED 7 COLOR SET UP BEADS, AND UNFORTUNATELY THE RESULTS WERE USED FOR INCLUSION/EXCLUSION IN A STUDY. CUSTOMER CONFIRMED THAT THERE WAS NO HARM, NEGATIVE IMPACT, OR INJURY TO THE PATIENT AS FAR AS THEY KNOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624451 BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS FLOW CTYOMETRIC REAGENTS AND ACESSORIES OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 85587 00382903389629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown