BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1035462 · Received May 1, 2008

    Report

    Report Number
    1034569-2008-00119
    Event Type
    Malfunction
    Date Received
    May 1, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 16, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FWD_ABORH TESTING WAS PERFORMED ON AN IN-HOUSE GALILEO WITH IN-HOUSE DONOR SAMPLES OF VARIOUS ABO/RH TYPES AND CUSTOMER'S RETURNED PATIENT SAMPLE. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. THE CUSTOMER'S SAMPLE WAS INTERPRETED AS GROUP B, RH POSITIVE.HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH THE PATIENT SAMPLE USING ANTI-A, LOT 101680, AND ANTI-B, LOT 203234. THE SAMPLE EXHIBITED VERY WEAK (+W) REACTIVITY AT IS WITH ANTI-A REAGENT AND STRONG POSITIVE (4+) REACTIVITY WITH ANTI-B. AFTER 15'RT INCUBATION, SAMPLE EXHIBITED 3+ MIXED-FIELD REACTIVITY. THE GALILEO OPERATOR MANUAL STATES ?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 AN ABO DISCREPANCY ON THE GALILEO FOR A NEONATAL PATIENT SAMPLE, USING THE FWD_ABO ASSAY. THE SAMPLE WAS B POSTIIVE ON THE INSTRUMENT, BUT AB POSITIVE IN MANUAL TESTING.

    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