BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 4242704 · Received November 11, 2014

    Report

    Report Number
    1034569-2014-00204
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 18, 2014
    Report Date
    November 10, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SITE DID NOT WISH TO AID INVESTIGATION OR PROVIDE ANY FURTHER INFORMATION. SITE DID NOT WANT TO AID INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED ABO MISTYPE WHEN TESTING A BLOOD SAMPLE ON A GALILEO ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725970 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR