BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1080697 · Received July 25, 2008

    Report

    Report Number
    1034569-2008-00262
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 9, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT WAS PERFORMED; INSPECTION OF REAGENT PROBE REVEALED THAT TIP INTEGRITY IS GOOD AND DAMPER IS IN PROPER POSITION. ALL PROBES HAD STRAIGHT AND SMOOTH DISPENSE FLOW. PROBE TEACHING POSITIONS WERE OPTIMIZED. THE POOL CELL ASSAY RAN WITH CONTROLS AND 6 SAMPLES;EXPECTED RESULTS WERE GENERATED. A REVIEW OF THE INSTRUMENT IMAGES SHOWED THAT SOME OF THE BUTTONS IN THE WELLS WERE SMALL AND LOOKED AS THOUGH THERE WERE NOT ENOUGH CELLS DISPENSED. TOLD CUSTOMER THAT THIS SOMETIMES MAY CAUSE UNEXPECTED POSITIVE RESULTS. THE CUSTOMER WAS TOLD TO BE SURE CELLS ARE WELL SUSPENDED AND STIR BALL HAVE BEEN ADDED BEFORE LOADING CELLULAR REAGENTS ON THE INSTRUMENT.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT AN RH DISCREPANCY ON GALILEO. DURING VALIDATION, A HISTORICALLY RH NEGATIVE DONOR REPORTED AS WEAK D POSITIVE.

    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