BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1022989 · Received April 3, 2008

    Report

    Report Number
    1034569-2008-00089
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 24, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT IMAGES WERE REVIEWED; THE UNEXPECTED RESULTS WERE CONFIRMED. 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. CUSTOMER LOADED THE MODIFIED ASSAY. SINCE LOADING THE FWD ASSAY MODIFICATION, THEY REPORTED THE ISSUES HAVE NOT REOCCURRED. 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 AN ABO MISTYPE ON THE GALILEO. A PATIENT HISTORICALLY TYPED AS AN A POSITIVE, BUT TYPED AS AN O POSITIVE ON THE GALILEO. THE SAMPLE WAS REPEATED AND GAVE THE EXPECTED REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC. 10054

    Patients

    Seq Age Sex Outcome Treatment
    1