BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX SUPERIOR ADHESIVE SLIDE - WHITE (1440)

    MDR report key: 21896535 · Received April 23, 2025

    Report

    Report Number
    1419341-2025-00026
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 28, 2025
    Report Date
    April 24, 2025
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.
    Product Code
    KEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER TESTING OF RETURNED SAMPLES WAS NOT ABLE TO REPLICATE THE "ADHESION IS NOT OPTIMAL" REPORTED BY THE CUSTOMER. THE ROOT CAUSE FOR THE "ADHESION IS NOT OPTIMAL" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. ALTHOUGH THE INFORMATION AVAILABLE INDICATES THAT NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER, THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT HAVE PREVIOUSLY RESULTED IN SERIOUS INJURY. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 28 MARCH 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "CUSTOMER IS COMPLAINING THAT ADHESION IS NOT OPTIMAL FOR SKIN SAMPLES, WHEN COMPARING TO THE PREVIOUS APEX SLIDES MANUFACTURED IN RICHMOND." ON 08 APRIL 2025, LEICA BIOSYSTEMS RECEIVED INFORMATION ADDITIONAL PATIENT TISSUE SAMPLES WERE AVAILABLE AND RE-BIOPSY WAS NOT RECOMMENDED OR PERFORMED. NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629119 APEX SUPERIOR ADHESIVE SLIDE - WHITE (1440) SLIDES, MICROSCOPE KEW LEICA BIOSYSTEMS RICHMOND INC. APEX SUPERIOR ADHESIVE SLIDE - WHITE (1440) 4900072396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown