BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1001588 · Received February 25, 2008

    Report

    Report Number
    1034569-2008-00031
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 9, 2008
    Report Date
    January 30, 2008
    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 INSTRUMENT IMAGES WERE REVIEWED AND APPEARED AS EXPECTED. TESTING PERFORMED WITH RETENTION ANTI-A, LOT 101673, 101674 WITH IN HOUSE DONOR SAMPLES REVEALED TYPE A RED CELL STICKING IN THE ANTI-A WELLS. TO PREVENT THE STICKING, IN HOUSE STUDIES FOUND THAT PIPETTING THE REAGENTS INTO THE WELLS BEFORE THE SAMPLE RED CELLS GREATLY REDUCED THE STICKING. IN HOUSE COMPARISON TESTING OF THE NEW REAGENT-FIRST PIPETTING ORDER TO THE EXISTING SAMPLE-FIRST PIPETTING ORDER SHOWED NO UNEXPECTED NEGATIVE ANTI-A REACTIONS WITH THE NEW PIPETTING ORDER. SOME UNEXPECTED NEGATIVE REACTIONS WERE OBSERVED DURING TESTING WITH THE CURRENT ASSAY. CUSTOMERS WERE NOTIFIED OF THE MODIFICATION TO THE ASSAY ON 9/20/07. THIS FACILITY DID NOT HAVE THE MODIFIED ABO ASSAY SOFTWARE INSTALLED.ACCORDING TO THE GALILEO OPERATOR MANUAL,FORWARD ONLY ABO-RH TESTING HAS A HIGHER RISK OF MISTYPE DUE TO THE ABSENCE OF THE REVERSE TYPE RESULTS. HAZARDOUS MISTYPES MAY OCCUR, SUCH AS AN A SAMPLE BEING INTERPRETED AS A GROUP AB, OR AN RH (D) NEGATIVE SAMPLE BEING INTERPRETED AS RH(D) POSITIVE. FOR THIS REASON, ABO-RH RESULTS SHOULD ALWAYS BE COMPARED TO THE PATIENT OR DONOR'S HISTORY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY HAVE HAD 4 OCCURANCES OF ABO MISTYPE (EXPECTED A TYPING AS O) ON DONOR SEGMENT SAMPLES TESTED WITH THE FWD-ABO ASSAY ON GALILEO.

    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