BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOND PLUS SLIDES

    MDR report key: 19043476 · Received April 4, 2024

    Report

    Report Number
    1419341-2024-00002
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    March 9, 2024
    Report Date
    April 4, 2024
    Manufacturer
    LEICA BIOSYSTEMS
    Product Code
    KES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 ONE (1) OTHER RELATED OCCURRENCE OF THIS ISSUE FOR THIS PRODUCT LOT. QUALITY CONTROL TESTING WAS COMPLETE AND PASSED. A CUSTOMER RETURNED SAMPLE ANALYSIS WAS COMPLETED. THERE IS NO DATA TO CONFIRM MANUFACTURING DEVIATION. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 09 MAR 2024 THE CUSTOMER REPORTED THAT 4 MICRON FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE) TISSUE HAS FALLEN OFF OF BOND PLUS SLIDES, P/N S21.2113.A, LOT 062723-9 AFTER IHC STAINING. ADDITIONAL SLIDES HAD TO BE CUT FROM THE PARAFFIN BLOCK. RE-BIOPSY WAS NOT REQUIRED FOR DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71148 BOND PLUS SLIDES COVERSLIPS, MICROSCOPE SLIDE KES LEICA BIOSYSTEMS BOND PLUS SLIDES 062723-9

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown