BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2971646 · Received February 21, 2013

    Report

    Report Number
    1034569-2013-00040
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 21, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS MADE AWARE OF TECHNICAL COMMUNICATION (B)(4) REGARDING PROPER/IMPROPER LOADING OF RACKS ON THE ECHO.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT GALILEO ECHO M00451 ASSIGNED THE INCORRECT SAMPLE IDENTIFIERS TO DONOR SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75485 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1