BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITE X-TRA SLIDES CASE, 1440, MADE IN USA

    MDR report key: 24694804 · Received March 25, 2026

    Report

    Report Number
    1419341-2026-00005
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 26, 2026
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.
    Product Code
    KEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE TISSUE DID NOT STICK TO WHITE X-TRA SLIDES CASE, 1440, MADE IN USA, P/N 3800200, LOT 073025-2. NO ADVERSE EVENTS WERE REPORTED. TRENDING ANALYSIS FROM (B)(6) 2025 TO (B)(6) 2026 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. THE PRODUCT HISTORY WAS REVIEWED AND DID NOT IDENTIFY INFORMATION IN THE MANUFACTURING RECORD FOR THIS PRODUCT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PROBLEM REPORTED IN THIS COMPLAINT. RETAIN SAMPLES FOR LOT 073025-2 WERE TESTED FOR TISSUE ADHESION. THREE DIFFERENT TISSUE TYPES (TONSIL, SKIN, AND LIVER) WERE CUT AND MOUNTED ON THE SLIDES. ALL SLIDES WERE RUN THROUGH AN H&E ON THE STAINER. UPON H&E COMPLETION, NO SLIDES SHOWED ANY ISSUES WITH TISSUE ADHESION. THE ROOT CAUSE COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2026, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED "TISSUE WILL NOT STICK TO SLIDES. THESE ARE THE NON-AE SLIDES." ON (B)(6) 2026, THE LEICA SENIOR SALES CONSULTANT ADVISED NO PATIENT TISSUE SAMPLES WERE LOST AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150162 WHITE X-TRA SLIDES CASE, 1440, MADE IN USA SLIDES, MICROSCOPE KEW LEICA BIOSYSTEMS RICHMOND INC. WHITE X-TRA SLIDES CASE, 1440, MADE IN USA 073025-2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown