BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2063748 · Received April 20, 2011

    Report

    Report Number
    1034569-2011-00043
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULT IMAGE FILES WERE REVIEWED BY AN IMMUCOR TECHNICAL SPECIALIST. WHILE THE INSTRUMENTS INTERPRETATION OF THE RESULTS WAS NEGATIVE, THE RESULTS VISUALLY APPEARED (B)(6) WITH CELL 1 ((B)(6)) AND NEGATIVE WITH CELLS 2 & 3 (BOTH K (B)(6)). CONTROLS PERFORMED AS EXPECTED. CUSTOMER WAS INFORMED OF THE NEED TO VISUALLY VERIFY ALL NEGATIVE ANTIBODY SCREENING AND IDENTIFICATION RESULTS. THE INSTRUMENT IS OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION ON THE GALILEO ECHO INSTRUMENT.

    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 55 YR