BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 2844356 · Received November 26, 2012

    Report

    Report Number
    1034569-2012-00221
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    September 1, 2012
    Report Date
    November 26, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS REFERRED TO THE LIMITATION SECTION OF THE OPERATOR MANUAL WHICH STATES THE GALILEO CANNOT RELIABLY DETECT HEMAGGLUTINATION REACTIONS THAT ARE GRADED AS 1+ OR LESS IN TEST TUBE METHODOLOGY. THE GALILEO DOES NOT GENERATE AN INTERPRETATION OF MIXED-FIELD. SUCH A MIXED-FIELD REACTION WILL BE INTERPRETED AS POSITIVE, NEGATIVE, OR EQUIVOCAL. THE INSTRUMENT IS OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER STATED THAT AN ABO DISCREPANCY OCCURRED BETWEEN MANUAL TUBE TESTING AND TESTING PERFORMED ON GALILEO ECHO INSTRUMENT (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR