BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19792932 · Received July 22, 2024

    Report

    Report Number
    1419341-2024-00007
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 22, 2024
    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. ISSUE IS CURRENTLY BEING INVESTIGATED. 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 041624-1 DOES NOT SEEM AS CHARGED AS THE PREVIOUS BATCHES. WHEN CUTTING WITH THE MICROTOME, AND FLOATING THE RIBBON ON THE WATER BATH, THE SPECIMENS KEEP FLOATING OFF EASILY, LIKE THE SLIDE IS NOT FULLY CHARGED/STICKY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736503 WHITE X-TRA SLIDES CASE, 1440, MADE IN USA COVERSLIPS, MICROSCOPE SLIDE KES LEICA BIOSYSTEMS WHITE X-TRA SLIDES CASE, 1440, MADE IN USA 041624-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown