BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOND PLUS SLIDES

    MDR report key: 19279828 · Received May 9, 2024

    Report

    Report Number
    1419341-2024-00004
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 28, 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

    D9 WAS UPDATED TO INCLUDE THE RETURN OF THE PRODUCT. F7/F8/G4/H3 WAS UPDATED REPORT TYPE AND DATE THE PRODUCT WAS RECEIVED. H6 UPDATED MEDICAL DEVICE PROBLEM CODE, TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSION CODE. 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.

    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 THAT THEY HAD FOUR (4) MICROMETER THICK TUMOR FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE) TISSUE FALLING OFF OF BOND PLUS SLIDES, P/N (B)(4).A, LOT 120723-9 AFTER BEING IHC STAINING ON ROCHE VENTANA BENCHMARK ULTRA AND LEICA BOND III MACHINE. ADDITIONAL SLIDES ERE RE-CUT FROM THE PARAFFIN BLOCK. RE-BIOPSY WAS NOT REQUIRED FOR DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484438 BOND PLUS SLIDES COVERSLIPS, MICROSCOPE SLIDE KES LEICA BIOSYSTEMS BOND PLUS SLIDES 120723-9

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown