BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC¿ FLOW CYTOMETER CEIVD

    MDR report key: 18624360 · Received February 1, 2024

    Report

    Report Number
    2916837-2024-00011
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    January 23, 2024
    Report Date
    May 1, 2024
    Manufacturer
    BECTON DICKINSON AND COMPANY BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906630292
    PMA / PMN Number
    K201814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5. THE EVENT DESCRIBED OCCURRED ON AN CE-IVD INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. 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

    BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF INCREASED INTENSITY FOR THE BV421 SIGNAL WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE DHR WAS REVIEWED TO ENSURE THAT THE INSTRUMENT MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE FSE TRIED TO IDENTIFY THE CAUSE AND COULD NOT REPLICATE THE ISSUE NOR DETERMINE THE PROBLEM AS THE INSTRUMENT WAS PERFORMING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ FLOW CYTOMETER CEIVD ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON FRIDAY 26JAN2024, ONE OF OUR ANALYSTS INFORMED US THAT HE OBSERVED AN INCREASED INTENSITY FOR THE BV421 SIGNAL IN ONE OF OUR ASSAYS. THIS INCREASED INTENSITY WAS OBSERVED FOR ALL SAMPLES STARTING FROM (B)(6) 2024 ONWARDS, WHICH IS THE DAY WHEN MAINTENANCE WAS PERFORMED ON BOTH INSTRUMENTS. WE HAVE RUN THE SAME SAMPLES ON ONE OF OUR OTHER INSTRUMENTS, AND THERE WE OBSERVE INTENSITIES COMPARABLE TO THE GRAPHS ON THE LEFT. BESIDES THIS, WE NOTICED THAT AFTER PERFORMING THE REQUIRED UPDATES (CQC, LNW/LW UPDATES, ADD FLUOROCHROMES), THE COMPENSATION MATRIX SHOWED A VERY HIGH VALUE (ABOUT 600%) FOR COMPENSATION BETWEEN EFLUOR506 AND BV421 AND V450. WE PERFORMED ALL UPDATES ONCE AGAIN, AND THEN THE ISSUE WAS RESOLVED. HOWEVER, KNOWING THAT WE ARE NOW EXPERIENCING THE ABOVE-MENTIONED TROUBLES WITH THE BV421 SIGNAL INTENSITY, WE SUSPECT SOMETHING WENT WRONG DURING THE YEARLY MAINTENANCE OF BOTH INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ FLOW CYTOMETER CEIVD ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON FRIDAY 26JAN2024, ONE OF OUR ANALYSTS INFORMED US THAT HE OBSERVED AN INCREASED INTENSITY FOR THE BV421 SIGNAL IN ONE OF OUR ASSAYS. THIS INCREASED INTENSITY WAS OBSERVED FOR ALL SAMPLES STARTING FROM 23JAN2024 ONWARDS, WHICH IS THE DAY WHEN MAINTENANCE WAS PERFORMED ON BOTH INSTRUMENTS. WE HAVE RUN THE SAME SAMPLES ON ONE OF OUR OTHER INSTRUMENTS, AND THERE WE OBSERVE INTENSITIES COMPARABLE TO THE GRAPHS ON THE LEFT. BESIDES THIS, WE NOTICED THAT AFTER PERFORMING THE REQUIRED UPDATES (CQC, LNW/LW UPDATES, ADD FLUOROCHROMES), THE COMPENSATION MATRIX SHOWED A VERY HIGH VALUE (ABOUT 600%) FOR COMPENSATION BETWEEN EFLUOR506 AND BV421 AND V450. WE PERFORMED ALL UPDATES ONCE AGAIN, AND THEN THE ISSUE WAS RESOLVED. HOWEVER, KNOWING THAT WE ARE NOW EXPERIENCING THE ABOVE-MENTIONED TROUBLES WITH THE BV421 SIGNAL INTENSITY, WE SUSPECT SOMETHING WENT WRONG DURING THE YEARLY MAINTENANCE OF BOTH INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073257 BD FACSLYRIC¿ FLOW CYTOMETER CEIVD FLOW CYTOMETRIC REAGENTS AND ACCESS OYE BECTON DICKINSON AND COMPANY BD BIOSCIENCES NA 00382906630292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown