BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1163324 · Received September 19, 2008

    Report

    Report Number
    1034569-2008-00445
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 21, 2008
    Report Date
    September 10, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE E, C AND JKA ANTIGENS WERE CONFIRMED ON RETENTION CRRS(I AND II), LOT X253, CRRID, LOTS ID104 AND DP029. CUSTOMER RETURNED SAMPLE FOR INVESTIGATION TESTING. TESTING IS ONGOING. THE CUSTOMER'S RETURNED SAMPLES WERE TESTED WITH RETENTION CRRS(I AND II), LOT X253 ON AN IN-HOUSE GALILEO INSTRUMENT. MODERATE TO STRONG REACTIVITY WAS OBSERVED WITH CELL II {(C-E+E-C+;JK(A+B-)}. THE SAMPLE WAS TESTED WITH RETENTION CRRID, LOT ID104 ON AN IN-HOUSE GALILEO. IDENTICAL REACTIVITY BETWEEN CUSTOMER'S TESTING AND OUR TESTING WAS OBSERVED WITH CELL 1 TO CELL 8, 10 AND 14. OUR IN-HOUSE GALILEO INSTRUMENT GAVE 1+ TO 2+ REACTIVITY IN CELL # 11, 12 AND 13 (DID NOT GIVE EQUIVOCAL (?) AS CUSTOMER OBSERVED). IN CELL 9, OUR GALILEO GAVE NEGATIVE REACTIVITY (CUSTOMER GOT (?) EQUIVOCAL REACTIVITY). WE CANNOT RULE OUT OTHER CLINICALLY SIGNIFICANT ALLOANTIBODIES. THE CUSTOMER'S SAMPLE WAS TESTED IN HEMAGGLUTINATION TESTS WITH SELECTED CELLS FROM PANOCELL-20, LOT 28841, USING IMMUADD AS THE POTENTIATOR. ONLY VERY WEAK MICROSCOPIC REACTIVITY WAS OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT AN ANTIBODY PANEL COMPLETED ON GALILEO SHOWED WEAK TO NO REACTIVITY ON A PATIENT WHICH HAD AN ANTI-C. THE CUSTOMER STATED THAT BASED ON THE REACTIVITY OF THE ANTIBODY ID PANEL, ANTI-C WAS RULED OUT. THE CUSTOMER INDICATED THAT THE UNEXPECTED REACTIONS DID NOT RESULT IN AN ADVERSE PATIENT EVENT.

    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 84 YR