BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2001404 · Received February 25, 2011

    Report

    Report Number
    1034569-2011-00022
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 25, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE MISTYPE IS AN ANOMALY IN THE COMMUNICATION BETWEEN THE INSTRUMENT AND THE SOFTWARE. THE ECHO LAMP IS TURNED OFF WHEN READING THE WELLS. DUE TO THE LACK OF ILLUMINATION, THE TEST WELL IMAGE APPEARS BLACK. IN RARE INSTANCES, SUCH AS THIS ONE, THE SYSTEM MAY GENERATE A FALSE TEST WELL INTERPRETATION. FOR HEMAGGLUTINATION-BASED ASSAYS, A FALSE NEGATIVE TEST WELL RESULT MAY BE GENERATED. FOR CAPTURE BASED ASSAYS, A FALSE POSITIVE TEST WELL RESULT MAY BE GENERATED. ADVISED CUSTOMER TO VIEW ALL RESULT IMAGES FOR BLANK/BLACK WELL APPEARANCE PRIOR TO RELEASE OF RESULTS AND TO REPEAT ANY SAMPLE THAT IS GIVEN A VALID INTERPRETATION WHEN THE CORRESPONDING IMAGE IS BLACKED OUT. ALSO ADVISED CUSTOMER IMMUCOR IS INVESTIGATING THE ISSUE AND WORKING ON A RESOLUTION. THIS ISSUE WAS COMMUNICATED TO CUSTOMERS IN TECHNICAL COMMUNICATION CC-10-037-01 ON FEBRUARY 15, 2011.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ABO MISTYPE ON THE ECHO. SAMPLE WAS TESTED INITIALLY ON THE NEO AND RESULTED AB POSITIVE. THE SAMPLE WAS TESTED ON THE ECHO AND RESULTED AS A NEGATIVE. THE SAMPLE WAS RE-TESTED ON THE ECHO AND RESULTED AB POSITIVE AS EXPECTED. THE SAMPLE WAS NOT TESTED BY MANUAL TUBE METHOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1