BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1961610 · Received January 14, 2011

    Report

    Report Number
    1034569-2011-00004
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 14, 2011
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE RESULT IMAGES, IT APPEARED THAT THE ANTI-A REAGENT WAS NOT DISPENSED INTO THE FIRST 6 OUT OF 10 COLUMNS OF THE PLATE DURING INITIAL TESTING. THE SAME VIAL OF ANTI-A REAGENT WAS USED UPON REPEAT TESTING AND THE EXPECTED RESULTS WERE OBTAINED. UNABLE TO RULE OUT THE POSSIBILITY OF AIR IN THE TUBING OR BUBBLES IN THE ACTUAL VIAL OF ANTI-A REAGENT. NO ADDITIONAL UNEXPECTED RESULTS WERE OBTAINED. THE INSTRUMENT IS OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN TESTING 6 DONOR SEGMENTS WITH THE ABO ASSAY ON THE GALILEO INSTRUMENT. THE CUSTOMER PERFORMED MANUAL TESTING AND OBTAINED THE EXPECTED POSITIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO BLOOD BANK ANALYZER KSZ IMMUCOR 10037

    Patients

    Seq Age Sex Outcome Treatment
    1