BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSTAINER LINK 48 INSTRUMENT SYSTEM

    MDR report key: 10394802 · Received August 12, 2020

    Report

    Report Number
    2022180-2020-00171
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    March 25, 2019
    Report Date
    August 12, 2020
    Manufacturer
    DAKO NORTH AMERICA, INC
    Product Code
    KPA
    UDI-DI
    05700572035497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS PART OF AGILENT'S CONTINUOUS IMPROVEMENT PROCESS, OUR PROCEDURES WERE REVIEWED AND IT WAS DETERMINED THAT THERE IS A NEED TO REPORT POTENTIAL RISKS ASSOCIATED WITH CRITICAL LIQUID DISPENSE SYSTEM COMPONENTS ON THE AUTOSTAINER. WE HAVE ASSESSED ALL AUTOSTAINER DISPENSE AND LEAKAGE COMPLAINTS FROM NOVEMBER OF 2017 THROUGH MARCH OF 2020 THAT RESULTED IN ALTERATION IN STAINING OR POTENTIAL ALTERATION IN SLIDE STAINING. FOLLOWING THIS REVIEW, IT WAS DECIDED TO RETROSPECTIVELY FILE AN MDR FOR CUSTOMER COMPLAINT (B)(4). THIS IS AN INITIAL REPORT. SUMMARY: BASED ON COMPLAINT REPORT OR INVESTIGATED FAILURE MODE, THERE WAS POTENTIAL FOR A STAINING ALTERATION. CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: LEAKAGE FROM REAGENT PROBE. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864185 AUTOSTAINER LINK 48 INSTRUMENT SYSTEM AUTOSTAINER LINK 48 INSTRUMENT SYSTEM KPA DAKO NORTH AMERICA, INC AS480 05700572035497

    Patients

    Seq Age Sex Outcome Treatment
    1 Other