BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISION FLEX

    MDR report key: 4988430 · Received August 10, 2015

    Report

    Report Number
    9610099-2015-00002
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 5, 2015
    Manufacturer
    DAKO DENMARK A/S
    Product Code
    LDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN INCREASING NUMBER OF COMPLAINTS REGARDING DAKO ENVISION FLEX DETECTION SYSTEMS HAS BEEN NOTED. SEVERAL OF THESE CUSTOMERS, USING A VARIETY OF ANTIBODIES (INCLUDING ANTIBODIES NOT MANUFACTURED BY DAKO), HAVE REPORTED NON-SPECIFIC BACKGROUND STAINING THAT HAS INTERFERED WITH INTERPRETATION OF THE STRAINING RESULTS. FOR THE MAJORITY OF PRIMARY ANTIBODIES, DETECTABILITY OF THIS POTENTIAL ISSUE IS HIGH SINCE THE EXPECTED STAINING PATTERN WOULD BE DIFFERENT FROM THE STRONG, UNIFORM NONSPECIFIC STAINING OBSERVED WITH THE MALFUNCTIONING ENVISION FLEX DETECTION SYSTEM. IF THE NON-SPECIFIC BACKGROUND STAINING IS NOT DETECTED BY THE PATHOLOGIST, AND THE STAINING PATTERN RESEMBLES THE EXPECTED STAINING PATTERN FOR THE PRIMARY ANTIBODY BEING USED, THIS POTENTIAL ISSUE COULD CAUSE AN INCORRECT DIAGNOSIS DUE TO A POTENTIAL FOR A FALSE POSITIVE TEST RESULT. THE ROOT CAUSE INVESTIGATION OF THIS ISSUE IS ONGOING, BUT APPEARS TO BE RELATED TO ONE SPECIFIC LOT OF THE DILUTION BUFFER USED IN THE PRODUCTION OF THE ENVISION FLEX/HRP VISUALIZATION REAGENT. THIS LOT OF DILUTION BUFFER WAS SUBSEQUENTLY USED IN THREE LOTS OF ENVISION FLEX/HRP. THERE HAS BEEN NO MISDIAGNOSIS KNOWN TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522019 ENVISION FLEX ENVISION FLEX LDT DAKO DENMARK A/S 20019098, 20019103, 20019102

    Patients

    Seq Age Sex Outcome Treatment
    1