BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 3113369 · Received May 15, 2013

    Report

    Report Number
    1034569-2013-00080
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 15, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE ECHO RESULT FILES FOR THE NEGATIVE ANTIBODY SCREEN SHOWED THAT CELL I VISUALLY APPEARED WEAK POSITIVE. IN-HOUSE TESTING OF RETENTION PRODUCT CONFIRMED THE PRESENCE OF THE JKA ANTIGEN ON THE CAPTURE-R READY-SCREEN (3) TEST WELLS. CUSTOMER WERE MADE AWARE OF TECHNICAL COMMUNICATION CC-09-042-02 WHICH ADVISES CUSTOMERS TO VISUALLY INSPECT ALL NEGATIVE ANTIBODY SCREENING AND IDENTIFICATION RESULTS ON THE ECHO PRIOR TO RELEASE OF RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIVITY ON THE ANTIBODY SCREENING ASSAY ON GALILEO ECHO M00675. AN ANTI-JKA WAS IDENTIFIED ON THE ANTIBODY IDENTIFICATION PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215292 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR