BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1018545 · Received March 26, 2008

    Report

    Report Number
    1034569-2008-00074
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 13, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE K ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY-SCREEN (I AND II), LOT X233, WITH ANTI-K. 2_CELL TESTING PERFORMED ON AN IN-HOUSE GALILEO WITH THE CUSTOMER'S RETURNED PATIENT SAMPLE USING RETENTION CAPTURE-R READY-SCREEN (I AND II), LOT X233, AND CAPTURE-R INDICATOR RED CELLS, LOT 221137. SAMPLE EXHIBITED 1+ REACTIVITY WITH CELL I (K+ DONOR B6443) AND WAS NONREACTIVE WITH CELL II (K- DONOR C3957). HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH CUSTOMER'S SAMPLE USING RETENTION PANOSCREEN I AND II, LOT 02458; IMMUADD WAS USED AS POTENTIATOR. SAMPLE EXHIBITED WEAK REACTIVITY (+W) AT IAT WITH K+ K+ CELL AND WAS NONREACTIVE WITH K- CELL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH A PATIENT SAMPLE TESTED ON THE GALILEO (2 CELL ASSAY).

    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