BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1920216 · Received December 10, 2010

    Report

    Report Number
    1034569-2010-00253
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 11, 2010
    Report Date
    December 10, 2010
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS MADE. INSTRUMENT WAS TESTED WITH NO ERRORS OBSERVED. THIS ISSUE WAS COMMUNICATED TO CUSTOMERS IN TECHNICAL COMMUNICATION CC-08-048-01 ON SEPTEMBER 30, 2008.

    Description of Event or Problem · 1

    CUSTOMER REPORTS AN ABO DISCREPANCY AFTER THE GALILEO MISREAD A SAMPLE ID. A SAMPLE LABELED AS (B)(6) WAS READ AS (B)(6) ON THE INSTRUMENT. AN ABO AND 2 CELL SCREEN WAS PERFORMED ON THE MISREAD SAMPLE AND WAS REPORTED OUT AS O POSITIVE WITH A NEGATIVE SCREEN. A MANUAL TYPE AND SCREEN WAS PERFORMED ON SAMPLE (B)(6) ON A DIFFERENT SPECIMEN TUBE AND WAS REPORTED OUT AS AB NEG WITH A NEGATIVE SCREEN. THE DATA MATCHED THE HISTORICAL RECORD FOR THIS PATIENT. THE CUSTOMER STATED A NEW SAMPLE LABEL WAS PRINTED, PLACED ON THE TUBE, AND THE SAMPLE ID READ CORRECTLY. THE CUSTOMER STATED NO ADVERSE EVENT OCCURRED AS A RESULT OF THE INCORRECT READING.

    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 77 YR