BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO NEO

    MDR report key: 3113393 · Received May 15, 2013

    Report

    Report Number
    1034569-2013-00083
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 21, 2013
    Report Date
    May 15, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK100033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSAY WAS MODIFIED TO DECREASE UNEXPECTED POSITIVE REACTIVITY AND EQUIVOCAL REACTIONS AND TO PROVIDE BETTER SPECIFICITY. PROVIDED THE ANTIBODY SCREEN WAS POSITIVE, ADDITIONAL TESTING WOULD NEED TO BE PERFORMED PRIOR TO TRANSFUSION. THE INSTRUMENT IS OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED UNEXPECTED NEGATIVE REACTIVITY DURING VALIDATION TESTING OF THE MODIFIED ANTIBODY IDENTIFICATION ASSAY ON THE GALILEO NEO (90168).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215369 GALILEO NEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR