BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 710166 · Received May 8, 2006

    Report

    Report Number
    1034569-2006-00012
    Event Type
    Malfunction
    Date Received
    May 8, 2006
    Date of Event
    January 10, 2006
    Report Date
    April 25, 2006
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WAS AN ABO MISTYPE ON THE GALILEO INSTRUMENT. INITIAL TESTING ON GALILEO REPORTED A RESULT OF O PENDING FROM A UNIT LABELED AS POSITIVE. ANOTHER SEGMENT WAS TESTED AND GAVE A RESULT OF A POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other