BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO NEO

    MDR report key: 7647118 · Received June 28, 2018

    Report

    Report Number
    1034569-2018-00162
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 9, 2018
    Report Date
    June 28, 2018
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234000648
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT COULD NOT USE REMOTE ELECTRONIC CONNECTION METHOD FOR ASSESSMENT. ON (B)(4) 2018 AN IMMUCOR FIELD SERVICE ENGINEER INSPECTED THE GALILEO NEO INSTRUMENT SERIAL NUMBER (B)(4) AND FOUND ROI'S IN NEED OF OPTIMIZATION. FSE OPTIMIZED ROI'S SUCCESSFULLY THEN RERAN SAMPLE WITH THE UNEXPECTED NEGATIVE AND IT RESULTED EQUIVOCAL. FSE ALSO RETRIEVE FILES NECESSARY FOR TS TO ASSESS CAMERA IMAGES, EVENT LOGS AND RESULT BATCHES. CAMERA IMAGES ARE OPTIMAL AND ALIGNED, EVENT LOG SHOWS NO ERRORS DURING PROCESSING AND SPECIMENS ARE ACCEPTABLE BASED ON COLOR CHECK IMAGES. ON 19JUN2018 IMMUCOR PERFORMED AN ANTIBODY SCREEN ON A NEO WITH RETURNED SAMPLE (B)(6) (CUSTOMER REPORTS THIS IS THE SAME PATIENT, THE ORIGINAL SPECIMEN WAS EXHAUSTED, THIS SAMPLE DRAWN THE SAME DAY) USING RETENTION CAPTURE R READY SCREEN I, II LOT X484 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221113. CONTROLS PERFORMED AS EXPECTED. RETURN SAMPLE RESULTED NEGATIVE WITH CELL 1 (FYA+B+) AND EQUIVOCAL WITH CELL 2 (FYA+B-). CELL 2 (FYA+B-) APPEARED VISUALLY POSITIVE. SAMPLE HAD EXHIBITED 2+ HEMOLYSIS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018 A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490153 GALILEO NEO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. X484 10888234000648

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR