BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 5695742 · Received June 2, 2016

    Report

    Report Number
    1034569-2016-00123
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 5, 2016
    Report Date
    June 2, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001584
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT RESULT FILES SHOW: THE THIRD TUBE (SAMPLE REDRAW) WAS RUN IN BATCH 15591 (R724 AND 221619) ALL CELLS WERE NEGATIVE. CELLS 2 AND 3 HAD LOOSE BUTTONS WITH RED CELL ADHERENCE AROUND THE BUTTON A SERVICE CALL WAS MADE AND INSTRUMENT WAS INSPECTED AND IS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN TESTING A PATIENT SAMPLE ON THE GALILEO ECHO INSTRUMENT. THE PATIENT HAS A HISTORY OF ANTI-E AND ANTI-FYA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348928 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. 10888234001584

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR