BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1004473 · Received March 3, 2008

    Report

    Report Number
    1034569-2007-00311
    Event Type
    Malfunction
    Date Received
    March 3, 2008
    Date of Event
    October 31, 2007
    Report Date
    November 27, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTWARE PATCH FOR THE FWD ABO ASSAY WAS INSTALLED ON THIS INSTRUMENT ON 10/16/07. CONTAMINATION OF THE REAGENT CAN BE RULED OUT BY THE FACT THAT THERE HAVE NOT BEEN NTDS OR UNEXPECTED REACTIONS SEEN WITH THE ABORH ASSAY. 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 3 SAMPLES THAT WERE HISTORICALLY A NEGATIVE HAVE TYPED AS AB NEGATIVE ON GALILEO. THE FWD ABO ASSAY WAS USED.

    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