BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1055834 · Received June 6, 2008

    Report

    Report Number
    1034569-2008-00182
    Event Type
    Malfunction
    Date Received
    June 6, 2008
    Date of Event
    May 15, 2008
    Report Date
    June 5, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REFLEXABO TESTING WAS PERFORMED ON AN IN-HOUSE GALILEO WITH CUSTOMER'S RETURNED DONOR SAMPLE AND IN-HOUSE DONOR SAMPLES OF VARIOUS ABO/RH TYPES. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. THE RETURNED SAMPLE WAS INTERPRETED AS B POSITIVE.HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH THE CUSTOMER'S SAMPLE USING RETENTION ANTI-A, LOT 101679, ANTI-A1 LECTIN, LOT 7G2137, ANTI-B SERIES 3, LOT 203234, A1 REFERENCELLS, LOT 111647, AND B REFERENCELLS, LOT 113647. AT IS, SAMPLE EXHIBITED +W REACTIVITY WITH ANTI-A, 4+ REACTIVITY WITH ANTI-B, 2+ REACTIVITY WITH A1 REFERENCELLS, AND WAS NONREACTIVE WITH ANTI-A1 LECTIN AND B REFERENCELLS. AFTER 15'RT AND 30'RT INCUBATION, SAMPLE EXHIBITED 1+ REACTIVITY WITH ANTI-A AND WAS NONREACTIVE WITH B REFERENCELLS AFTER 15"RT INCUBATION. THE SAMPLE APPEARS TO BE AN ASUBB WITH AN ANTI-A1. THE EVENT APPEARS RELATED TO THE NATURE OF THE SAMPLE. THE GALILEO OPERATOR MANUAL STATES: "WARNING: THE GALILEO CANNOT RELIABLY DETECT HEMAGGLUTINATION REACTIONS THAT ARE GRADED AS 1+ OR LESS IN TEST TUBE METHODOLOGY."

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A DONOR WITH A HISTORY OF TYPING AB POSITIVE TYPED AS B POSITIVE ON THE GALILEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC. 10053

    Patients

    Seq Age Sex Outcome Treatment
    1