BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO NEO

    MDR report key: 2498173 · Received March 21, 2012

    Report

    Report Number
    1034569-2012-00050
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 20, 2012
    Report Date
    March 21, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK100001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMAGE RESULT FILES WERE REVIEWED BY AN IMMUCOR TECHNICAL SUPPORT SPECIALIST. THE IMAGES AGREED WITH THE INSTRUMENT INTERPRETATION. NO ROI MISALIGNMENT NOTED. NO PINHOLES WERE PRESENT IN THE CELL BUTTONS. POSITIVE AND NEGATIVE CONTROLS APPEARED VISUALLY POSITIVE AND NEGATIVE AS EXPECTED. UNABLE TO RULE OUT A SAMPLE-RELATED ISSUE AS THE CAUSE OF THE UNEXPECTED NEGATIVE REACTIVITY. IN ADDITION, THE INSTRUMENT INTERPRETATION WAS AT THE CUSP OF DETECTION. THE SAMPLE REACTED POSITIVE WHEN REPEATED MANUALLY WITH UNPOOLED DONORS. CUSTOMER WAS REFERRED TO THE LIMITATION SECTION OF THE PACKAGE INSERT WHICH STATES, "ANTIBODY SCREENING TESTS EMPLOYING POOLED REAGENT RED BLOOD CELLS WILL NOT BE AS SENSITIVE AS THOSE INCORPORATING THE RED BLOOD CELLS OF UNPOOLED SINGLE DONORS. POOLED REAGENT RED BLOOD CELLS SHOULD NOT BE USED WHEN THE ANTIGLOBULIN ANTIBODY SCREEN IS PERFORMED IN PLACE OF THE ANTIGLOBULIN CROSSMATCH." THE INSTRUMENT IS OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIONS WERE OBTAINED WITH THE POOLED CELL SCREEN FOR A DONOR SAMPLE TESTED ON NEO INSTRUMENT (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR