BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISAN GOMORI'S BLUE TRICHROME STAIN KIT

    MDR report key: 10678730 · Received October 14, 2020

    Report

    Report Number
    2022180-2020-00358
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 15, 2020
    Report Date
    October 14, 2020
    Manufacturer
    DAKO NORTH AMERICA INC.
    Product Code
    KFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: ALTERATION OF ASSAY AND STAINING IN THIS CASE WAS NOT CONFIRMED. THE PROBLEM WAS INVESTIGATED BY A FIELD SERVICE ENGINEER. THIS INVESTIGATION DID NOT IDENTIFY ANY INSTRUMENT MALFUNCTION OR ALTERATION IN INSTRUMENT PERFORMANCE. THE INSTRUMENT REMAINS FULLY OPERATIONAL WITHIN SPECIFICATIONS, WITHOUT ERRORS AND AVAILABLE FOR THE USER. FAILURE MODE DESCRIPTION: AS NO MALFUNCTION WERE FOUND AFTER COMPLETION OF INVESTIGATION; THE FAILURE MODE COULD NOT BE VERIFIED AS AN INSTRUMENT OR PRODUCT SPECIFIC MALFUNCTION. THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: INCONSISTENT STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146354 ARTISAN GOMORI'S BLUE TRICHROME STAIN KIT ARTISAN GOMORI'S BLUE TRICHROME STAIN KIT KFD DAKO NORTH AMERICA INC. AR167 11161727

    Patients

    Seq Age Sex Outcome Treatment
    1