BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1202643 · Received October 21, 2008

    Report

    Report Number
    1034569-2008-00513
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 10, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ABORH TESTING WAS PERFORMED WITH IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES, USING RETENTION ANTI-A, LOT 101676, AND ANTI-B SERIES 3, LOT 203224, ON IN-HOUSE GALILEO. THESE REAGENTS WERE USED AT THE TIME OF THE EVENT. A1 REFERENCELL, LOT 111664, AND B REFERENCELL, LOT 113664, WERE USED FOR REVERSE GROUPING. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. ABORH TESTING WAS PERFORMED WITH THE CUSTOMER'S RETURNED DONOR SAMPLE, USING RETENTION ANTI-A, LOT 101676, AND ANTI-B SERIES 3, LOT 203224, ON AN IN-HOUSE GALILEO. A1 REFERENCELL, LOT 111664, AND B REFERENCELL, LOT 113664, WERE USED FOR REVERSE GROUPING. THE SAMPLE WAS INTERPRETED AS B-POSITIVE. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH THE CUSTOMER'S DONOR SAMPLE, USING RETENTION ANTI-A, LOT 101676, AND ANTI-B SERIES 3, LOT 203224. A1 REFERENCELL, LOT 111668, A2 REFERENCELL, LOT 112566, B REFERENCELL, LOT 113668 R, AND O REFERENCELL, LOT 114072, WERE USED FOR REVERSE GROUPING. THE SAMPLE EXHIBITED 4+ REACTIVITY WITH ANTI-B AND 1+ REACTIVITY WITH A1 REFERENCELLS AT IS. THE SAMPLE WAS INCUBATED AT RT WITH ANTI-A FOR 60-MINUTES;IT EXHIBITED 1+ MIXED-FIELD REACTIVITY. THE GALILEO OPERATOR MANUAL INDICATES THAT THE GALILEO DOES NOT DIFFERENTIATE MIXED FIELD REACTIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT A DONOR SAMPLE WAS TESTED ON THE GALILEO AND RESULTED AS B POSITIVE. THE UNIT HAD BEEN LABELED AS A B POSITIVE UNIT. IT WAS SENT OUT TO A HOSPITAL; THE UNIT SEGMENT THEY TESTED RESULTED AS AB POSITIVE.

    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