BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 710216 · Received May 8, 2006

    Report

    Report Number
    1034569-2006-00016
    Event Type
    Malfunction
    Date Received
    May 8, 2006
    Date of Event
    April 4, 2006
    Report Date
    May 3, 2006
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RH MISTYPE OF O NEGATIVE ON A PATIENT WHO WAS PREVIOUSLY TYPED AS O POSITIVE AT THE FACILITY.

    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