BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19801666 · Received July 22, 2024

    Report

    Report Number
    1419341-2024-00009
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 12, 2024
    Report Date
    October 10, 2025
    Manufacturer
    LEICA BIOSYSTEMS
    Product Code
    KES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS LOT. TRENDING ANALYSIS REPORTED NO OTHER RELATED OCCURRENCE OF THIS ISSUE FOR THIS PRODUCT LOT. QUALITY CONTROL TESTING WAS COMPLETE AND PASSED. A RETAIN SAMPLE ANALYSIS WAS COMPLETED AND PASSED. THERE IS NO DATA TO CONFIRM MANUFACTURING DEVIATION. I. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED WHITE X-TRA SLIDES CASE, 1440, MADE IN USA, P/N 3800200, LOT 052124-1 WERE NOT CHARGED. THE TISSUE WAS FLOATING OFF THE SLIDE IN THE WATER BATH. THERE WAS NO REPORT OF TISSUE LOSS OR RE-BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003920 WHITE X-TRA SLIDES CASE, 1440, MADE IN USA COVERSLIPS, MICROSCOPE SLIDE KES LEICA BIOSYSTEMS WHITE X-TRA SLIDES CASE, 1440, MADE IN USA 052124-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown