BEUDAMED
    FDA Adverse Event Other Summary report: N

    GALILEO

    MDR report key: 782526 · Received August 30, 2006

    Report

    Report Number
    1034569-2006-00093
    Event Type
    Other
    Date Received
    August 30, 2006
    Date of Event
    August 1, 2006
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT IMAGES WERE REVIEWED AND APPEARED NORMAL EXCEPT FOR ONE OF THE WELLS THAT RESULTED AS NEGATIVE, BUT APPEARED TO BE POSITIVE ACCORDING TO THE IMAGE. CUSTOMER RETURNED A SAMPLE FOR INVESTIGATION TESTING. NO UNEXPECTED REACTIVITY WAS OBSERVED. THE E AND K ANTIGENT WERE CONFIRMED ON RETENTION CAPTURE R READY SCREEN (4), LOT K098. IN-HOUSE DONOR SAMPLES WERE TESTED WITH RETENTION CRRS, LOT K098, ON A GALILEO USING RETENTION CRRIC, LOT 221907. NO UNEXEPCTED REACTIVITY WAS OBSERVED. RETENTION PRODUCTS PERFORMED AS EXPECTED. A SERVICE CALL WAS PERFORMED. THE CAMERA SETTINGS WERE ADJUSTED AND NEW FLAT FIELD IMAGES WERE TAKEN. THIS IS THE MOST LIKELY CAUSE OF THE EVENT. THE INSTRUMENT PERFORMED AS A EXPECTED FOLLOWING THE SERVICE CALL.

    Description of Event or Problem · 1

    ANTI-E AND ANTI-K ANTIBODIES WERE IDENTIFIED IN A PT SAMPLE WITH MANUAL TESTING USING CAPTURE R READY SCREEN 4 (CRRS). THE ANTIBODIES WERE NOT DETECTED ON THE GALILEO INSTRUMENT USING THE 4_CELL SCREEN ASSAY. NO MEDICAL ACTION WAS TAKEN BASED ON THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO KSZ KSZ IMMUCOR, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 CELLS, LOT 221907.| CRRS (4), LOT K098, CAPTURE R READY INDICATOR