BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2120117 · Received June 10, 2011

    Report

    Report Number
    1034569-2011-00065
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 10, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE CAPTURE-R READY-SCREEN 3 RESULTS SHOWS THAT THE SAMPLE WAS VISUALLY POSITIVE FOR CELL 3 (K POSITIVE). THE REACTION IN CELL 3 WAS INTERPRETED AS NEGATIVE, BUT VISUALLY APPEARED POSITIVE WITH A SLIGHTLY FUZZY BUTTON AND LIGHT ADHERENCE SEEN IN THE BACKGROUND OF THE WELL. THE POSITIVE CONTROL WELL REACTED AS EXPECTED. CUSTOMER HAD IDENTIFIED AN ANTI-K IN THE SAMPLE ON THE ECHO CAPTURE-R READY ID (CRRID) ASSAY. REVIEW OF THE CRRID RESULTS SHOWS THAT THE SAMPLE WAS NEGATIVE FOR ALL CELLS. VISUALLY THE SAMPLE WAS POSITIVE FOR CELL 7 (HOMOZYGOUS FOR K), BUT INTERPRETED AS NEGATIVE. THE REACTION VISUALLY APPEARED POSITIVE WITH A SLIGHTLY FUZZY BUTTON AND LIGHT ADHERENCE SEEN IN THE BACKGROUND OF THE WELL. THIS ISSUE WAS ADDRESSED UNDER CUSTOMER COMMUNICATION CC-09-042-02 WHERE THE ECHO MAY INTERPRET REACTIONS THAT APPEAR WEAK POSITIVE AS NEGATIVE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY OCCURRING ON A PATIENT SAMPLE WHEN 3 CELL SCREEN WAS PERFORMED ON GALILEO ECHO. A SAMPLE WITH AN ANTI-K REACTED NEGATIVE ON THE ECHO, BUT VISUALLY APPEARED POSITIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR