BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX IHC MICROSCOPE SLIDES

    MDR report key: 10994706 · Received December 12, 2020

    Report

    Report Number
    9610099-2020-00050
    Event Type
    Malfunction
    Date Received
    December 12, 2020
    Date of Event
    November 6, 2020
    Report Date
    December 11, 2020
    Manufacturer
    AGILENT TECHNOLOGIES DENMARK APS
    Product Code
    KEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: ALTERATION OF STAINING IN THIS CASE WAS DUE TO OFF-LABEL USAGE OF THE FLEX IHC MICROSCOPIC SLIDES. THE PROBLEM WAS SOLVED BY REPLACING THE SLIDES. FOLLOWING THE REPLACEMENT OF SLIDES, THE RESULTS HAVE NOT SHOWN ANY DIAGNOSTICS PROBLEMS. THE SLIDES ARE INTENDED FOR MOUNTING FORMALIN-FIXED, PARAFFIN-EMBEDDED TISSUE SECTIONS USED IN IMMUNOHISTOCHEMISTRY WITH DAKO ENVISION FLEX VISUALIZATION SYSTEMS. CUSTOMER USED THE SLIDES OFF LABEL. AGILENT HAS VERIFIED THAT ALL RELEASED LOTS OF FLEX IHC MICROSCOPE SLIDES PERFORMED ACCORDING TO THEIR INTENDED USE. FAILURE MODE DESCRIPTION: PER THE INSTRUCTIONS FOR USE (IFU) OF THE DAKO FLEX IHC SLIDES, THE SLIDES ARE COMPATIBLE WITH DAKO INSTRUMENTS. FOLLOWING THE USAGE OF FLEX IHC SLIDES ON A NON-DAKO INSTRUMENT, THE RESULTING FAILURE MODES DESCRIBED COULD POTENTIALLY OCCUR WEAK STAINING, FALSE NEGATIVE STAINING, UNRELIABLE COUNTERSTAINING, PARTIAL STAINING, AND HYDROPHOBICITY ISSUES. POTENTIAL SLIDE MALFUNCTION IS HIGHLY DETECTABLE BY TRAINED PATHOLOGISTS. THEREFORE, THE LIKELIHOOD OF AN ERRONEOUS STAINING RESULT LEADING TO SERIOUS INJURY IS DEEMED AS REMOTE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: "HYDROPHOBICITY ISSUES". THIS WAS DUE TO OFF-LABEL USAGE OF THE FLEX IHC SLIDES. NO DIRECT, OR INDIRECT PATIENT HARM, OR USER HARM HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459856 FLEX IHC MICROSCOPE SLIDES MICROSCOPE SLIDE KEW AGILENT TECHNOLOGIES DENMARK APS K8020 20200306

    Patients

    Seq Age Sex Outcome Treatment
    1