BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITE X-TRA SLIDES CASE

    MDR report key: 10374253 · Received August 6, 2020

    Report

    Report Number
    1419341-2020-00001
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    July 8, 2020
    Report Date
    August 31, 2020
    Manufacturer
    LEICA BIOSYSTEMS
    Product Code
    KES
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REVIEW WAS COMPLETED. THERE WAS NO DEVIATIONS OR NON-CONFORMNACESS ASSOCIATED WITH THIS LOT. QUALITY CONTROL TESTING WAS COMPLETE AND PASSED. PRODUCT WAS DISCARDED BY THE CUSTOMER, THEREFORE, ADDITIONAL TESTING ON THE SLIDE CANNOT BE COMPLETED. A RETAIN SAMPLE ANALYSIS WAS COMPLETED. THERE WERE 30 RANDOMLY SELECTED SLIDES TESTED. ALL 30 SLIDES HAD THE TISSUE REMAIN INTACT. THE ISSUE OF TISSUE NOT ADHERISING TO THE WHITE X-TRA SLIDES CASE, P/N 3800200, LOT 032620 WAS NOT CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ISSUE IS CURRENTLY BEING INVESTIGATED. ADDITIONAL INFORMATION OR INVESTIGATION RESULTS WILL BE SUBMITTED PENDING INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE CUSTOMER REPORTED TISSUE LOSS THAT WAS CUT AT 4-5 MICRONS THAT REQUIRED RE-BIOPSY OF THE PATIENT. THE TISSUE LOSS WAS FOUND DURING STAINING WITH IMMUNOHISTOCHEMISTRY ON A BOND INSTRUMENT. RE-BIOPSY OF THE PATIENT WAS NECESSARY FOR DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835877 WHITE X-TRA SLIDES CASE WHITE X-TRA SLIDES CASE KES LEICA BIOSYSTEMS NA 032620

    Patients

    Seq Age Sex Outcome Treatment
    1 Other