BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSTAINER LINK 48

    MDR report key: 10347610 · Received July 30, 2020

    Report

    Report Number
    2022180-2020-00041
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    June 18, 2018
    Report Date
    July 30, 2020
    Manufacturer
    DAKO NORTH AMERICA, INC.
    Product Code
    KPA
    UDI-DI
    05700572035497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 (B)(6) 2017 THROUGH (B)(6) 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 AND FINAL REPORT COMBINED. SUMMARY: BASED ON COMPLAINT REPORT OR INVESTIGATED FAILURE MODE, THERE WAS POTENTIAL FOR A STAINING ALTERATION. CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: BUBBLES PRESENT IN THE REAGENT TUBE. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812612 AUTOSTAINER LINK 48 AUTOSTAINER LINK 48 INSTRUMENT SYSTEM KPA DAKO NORTH AMERICA, INC. AS480 05700572035497

    Patients

    Seq Age Sex Outcome Treatment
    1 Other