BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LEUCOCOUNT¿

    MDR report key: 17172509 · Received June 21, 2023

    Report

    Report Number
    2647876-2023-00051
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    May 30, 2023
    Report Date
    March 11, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    GKZ
    UDI-DI
    00382903405237
    PMA / PMN Number
    BK970046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: G.1. REPORTING OFFICE: (B)(6). H.6. IMDRF ANNEX F GRID: F26. H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF ERRORS IN THE EIFU FOR 340523 LEUCOCOUNT HUMAN REAGENT KIT WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: PHOTOS OF EFU 23-3434 (12) WAS REVIEWED AND SHOWED THE FOLLOWING ERRORS. ON PAGE 8 FOR RUNNING THE ASSAY ON BD FACS CALIBUR FLOW CYTOMETERS, IT STATES, ¿TO PERFORM MANUAL SETUP USING BD FACSCOMP¿ SOFTWARE.¿ ON PAGE 9 FOR RUNNING THE ASSAY ON BD FACS CALIBUR FLOW CYTOMETERS, IT STATES, ¿TO ACQUIRE THE SAMPLES USING BD FACSCOMP¿ SOFTWARE.¿ THE SECTION OF THE EIFU SHOULD STATE BD CELLQUEST¿ PRO SOFTWARE INSTEAD OF BD FACSCOMP¿ SOFTWARE. FOR THE LABEL REVIEW, THE LATEST REVISION OF THE EIFU IN SAP IS 23-3434 (14) WAS REVIEWED. ON PAGE 8 FOR RUNNING THE ASSAY ON BD FACS CALIBUR FLOW CYTOMETERS, IT STATES, ¿TO PERFORM MANUAL SETUP USING BD FACSCOMP¿ SOFTWARE.¿ THIS SECTION STILL NEEDS TO BE CORRECTED FROM BD FACSCOMP¿ SOFTWARE TO BD CELLQUEST¿ PRO SOFTWARE IN THE FUTURE EIFU RELEASE. ON PAGE 10 FOR RUNNING THE ASSAY ON BD FACS CALIBUR FLOW CYTOMETERS, IT STATES, ¿TO ACQUIRE THE SAMPLES USING BD CELLQUEST¿ PRO SOFTWARE.¿ THIS SECTION HAS BEEN CORRECTED. BHR PART # 340523 LOT # 3101059 WAS REVIEWED. THE PRODUCT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE POTENTIAL CAUSE OF THE ERRORS OF EIFU WAS DUE TO WRONG SOFTWARE REFERENCED FOR MANUAL SETUP. THE PUBLICATIONS DEPARTMENT HAS BEEN NOTIFIED AND QUALITY NOTIFICATION WAS INITIATED. THIS IS THE ONLY COMPLAINT FOR EIFU ERROR. 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.

    Additional Manufacturer Narrative · 0

    E.4 INITIAL REPORTER PHONE # (B)(6). H.3. 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 WHILE USING THE BD LEUCOCOUNT¿ THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ERRORS HAVE CREPT INTO THE NEW EIFU, BOTH IN THE ENGLISH VERSION AND PROBABLY IN ALL TRANSLATIONS (AT LEAST THE GERMAN ONE). IN THE MANUAL INSTRUMENT SETUP AS WELL AS IN THE MEASUREMENT OF THE DATA ON THE CALIBUR IT IS REFERRED TO THAT ONE SHOULD USE THE BD FACSCOMP SOFTWARE. THIS IS NOT CORRECT. THE BD FACSCOMP SOFTWARE CANNOT DO THIS, RATHER THE BD CELLQUEST PRO SOFTWARE IS USED FOR THIS. (THIS IS AN ERROR THAT WAS ALREADY PARTIALLY PRESENT IN THE OLD TECHNICAL DATASHEET AND HAS PROBABLY NOT BEEN IMPROVED). PAGE 8 TO PERFORM MANUAL SETUP USING BD FACSCOMP¿ SOFTWARE: (MUST BE BD CELLQUEST PRO SOFTWARE). PAGE 9 TO ACQUIRE THE SAMPLES USING BD FACSCOMP¿ SOFTWARE: (MUST BE BD CELLQUEST PRO SOFTWARE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD LEUCOCOUNT¿ THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ERRORS HAVE CREPT INTO THE NEW EIFU, BOTH IN THE ENGLISH VERSION AND PROBABLY IN ALL TRANSLATIONS (AT LEAST THE GERMAN ONE). IN THE MANUAL INSTRUMENT SETUP AS WELL AS IN THE MEASUREMENT OF THE DATA ON THE CALIBUR IT IS REFERRED TO THAT ONE SHOULD USE THE BD FACSCOMP SOFTWARE. THIS IS NOT CORRECT. THE BD FACSCOMP SOFTWARE CANNOT DO THIS, RATHER THE BD CELLQUEST PRO SOFTWARE IS USED FOR THIS. (THIS IS AN ERROR THAT WAS ALREADY PARTIALLY PRESENT IN THE OLD TECHNICAL DATASHEET AND HAS PROBABLY NOT BEEN IMPROVED). PAGE 8. TO PERFORM MANUAL SETUP USING BD FACSCOMP¿ SOFTWARE: (MUST BE BD CELLQUEST PRO SOFTWARE). PAGE 9. TO ACQUIRE THE SAMPLES USING BD FACSCOMP¿ SOFTWARE: (MUST BE BD CELLQUEST PRO SOFTWARE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216182 BD LEUCOCOUNT¿ COUNTER, DIFFERENTIAL CELL GKZ BECTON DICKINSON CARIBE LTD. 340523 3101059 00382903405237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown