BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSTAINER LINK 48

    MDR report key: 3520939 · Received December 11, 2013

    Report

    Report Number
    MW5033387
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    November 11, 2013
    Report Date
    December 10, 2013
    Manufacturer
    DAKO
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IHC INSTRUMENT MALFUNCTION. INTERMITTENT FAILURE TO DISPENSE ANTIBODY ONTO TISSUES (SLIDES). ANTIBODY H PYL DISPENSED APPROPRIATELY ONTO CONTROL WHICH PERFORMED AS EXPECTED. HOWEVER, ANTIBODY FAILED TO DISPENSE ONTO PT'S TISSUE. CONTROL PERFORMED AS EXPECTED AND PT APPEARED TO BE H.PYL NEGATIVE. UPON CASE REVIEW, PATHOLOGIST ORDERED TEST REPEATED WHICH WAS POSITIVE. (B)(4) DETERMINED FAULTY PROGRAMMING OF ANTIBODY DISPENSING VOLUME TO BE ROOT CAUSE OF FALSE NEGATIVE. VOLUMES WERE PROGRAMMED THAT WERE INCONSISTENT WITH DAKO'S MINIMUM VOLUME REQUIREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646900 AUTOSTAINER LINK 48 AUTOSTAINER LINK 48 KPA DAKO AUTOSTAINER LINK 48

    Patients

    Seq Age Sex Outcome Treatment
    1 Other