BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 806403 · Received January 5, 2007

    Report

    Report Number
    1034569-2007-00006
    Event Type
    Malfunction
    Date Received
    January 5, 2007
    Date of Event
    December 8, 2006
    Report Date
    January 5, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS PERFORMED AND THE INSTRUMENT ROIS WERE ADJUSTED. THE PRESENCE OF THE FYA ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY-SCREEN (POOLED CELLS) [CRRS], LOT N103. CUSTOMER RETURNED SAMPLE FOR INVESTIGATION TESTING. THE SAMPLE WAS NONREACTIVE WITH CRRS (POOLED), LOT N103. THE SAMPLE WAS TESTED WITH CAPTURE-R READY-SCREEN (I & II), LOT X170 WHICH UTILIZES UNPOOLED SINGLE DONORS. MODERATE REACTIVITY WAS OBSERVED WITH THE FY (A+) CELL. THE SAMPLE WAS TESTED BY MANUAL TUBE METHOD WITH SELECTED FY (A+) AND FY (A-) REAGENT RED BLOOD CELLS AND HEMANTIGEN (POOLED CELLS), LOT 43524 USING IMMUADD AS THE POTENTIATOR. THE SAMPLE EXHIBITED WEAK REACTIVITY WITH THE HEMANTIGEN (POOLED CELLS) AND THE FY (A+) CELLS. THE VENT APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLE. THE PACKAGE INSERT FOR CAPTURE-R READY-SCREEN (POOLED CELLS) 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."

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREEN ON THE GALILEO WITH A DONOR SAMPLE WITH HISTORY OF ANTI-FYA USING CAPTURE-R READY-SCREEN (POOLED), LOT N103. ANTIBODY ID TESTING ON THE GALILEO CONFIRMED THE ANTI-FYA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO KSZ KSZ IMMUCOR, INC. 10025 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *