BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO NEO

    MDR report key: 3821887 · Received May 20, 2014

    Report

    Report Number
    1034569-2014-00079
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 10, 2014
    Report Date
    May 20, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK100001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE INSTRUMENT TEST WELL IMAGES ON (B)(4) 2014. THE REVIEW OF THE WELL IMAGES WAS CONSISTENT WITH THE GALILEO NEO INTERPRETATION. IMMUCOR TESTED RETENTION PRODUCT ON (B)(4) 2014, WHICH PERFORMED AS EXPECTED. IMMUCOR TESTED CUSTOMER RETURNED BLOOD SAMPLES ON (B)(4) 2014 AND WAS NOT ABLE TO REPRODUCE THE CUSTOMERS OBSERVATIONS. AN IMMUCOR FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE ON (B)(4) 2014 AND SUBSEQUENTLY ADJUSTED THE RESIDUAL VOLUME FROM 1.30 GRAMS TO 0.70 GRAMS (THE RANGE IS 0.30 GRAMS TO 0.80 GRAMS). FOLLOWING THIS RESIDUAL VOLUME CORRECTION, THE CUSTOMER THEN RAN MULTIPLE BLOOD SAMPLES AND THEY RESULTED AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED ANTIGEN NEGATIVE MISTYPE RESULT WHEN TESTING A RED BLOOD CELL DONATION ON A GALILEO NEO INSTRUMENT ON (B)(6) 2014. THE EXPECTED RESULT WAS ANTIGEN POSITIVE. THE CONSEQUENCE OF THIS EVENT WAS THE TRANSFUSION OF AN ANTIGEN POSITIVE RED BLOOD CELL UNIT TO A PATIENT WHO POSSESSED THE CORRESPONDING CLINICALLY SIGNIFICANT ANTIBODY, WHICH THEN RESULTED IN A HEMOLYTIC TRANSFUSION REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300138 GALILEO NEO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other