BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSTAINER LINK 48

    MDR report key: 10341856 · Received July 29, 2020

    Report

    Report Number
    2022180-2020-00028
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    November 5, 2018
    Report Date
    July 29, 2020
    Manufacturer
    DAKO NORTH AMERICA, INC.
    Product Code
    KPA
    UDI-DI
    05700572035497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS PART OF OUR CONTINUOUS IMPROVEMENT PROCESS, WE HAVE REVIEWED OUR PROCEDURES AND DETERMINED THAT THERE IS A NEED TO INCREASE THE REPORTING OF POTENTIAL RISKS ASSOCIATED WITH LEAKAGE 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) AS MDR. 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: LEVEL SENSING FAILURE. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806107 AUTOSTAINER LINK 48 AUTOSTAINER LINK 48 INSTRUMENT SYSTEM KPA DAKO NORTH AMERICA, INC. AS480 05700572035497

    Patients

    Seq Age Sex Outcome Treatment
    1 Other