BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2101214 · Received May 24, 2011

    Report

    Report Number
    1034569-2011-00061
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 17, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS MADE. THE REAGENT PROBE WAS REPLACED. THE SAMPLE WAS RE-TESTED AND RESULTED AS EXPECTED. THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTION ON THE ECHO. THE SAMPLE HAD AN ANTI-C AND ANTI-E.

    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 80 YR