BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1102343 · Received August 11, 2008

    Report

    Report Number
    1034569-2008-00311
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 8, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ABORH WAS TESTING PERFORMED ON AN IN-HOUSE GALILEO WITH IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES AND THE CUSTOMER'S RETURNED SAMPLE, USING RETENTION ANTI-A, LOT 101682, AND ANTI-B SERIES 3, LOT 203236. A1 REFERENCELLS, LOT 111655, AND B REFERENCELLS, LOT 113655, WERE USED FOR REVERSE GROUP TESTING. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. THE RETURNED SAMPLE WAS INTERPRETED AS A POSITIVE, AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ABO DISCREPANCY ON GALILEO. A PATIENT SAMPLE RESULTED AS O POSITIVE. THE PATIENT IS A HISTORICAL A POSITIVE AND PREVIOUSLY RECEIVED 2 UNITS OF A POSITIVE RED BLOOD CELLS.

    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 58 YR