BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO V2

    MDR report key: 8555915 · Received April 26, 2019

    Report

    Report Number
    1034569-2019-00087
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    April 11, 2019
    Report Date
    April 26, 2019
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001584
    PMA / PMN Number
    BK170132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON APRIL 12, 2019 IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS FILES ON GALILEO ECHO V2 INSTRUMENT SERIAL NUMBER (B)(4); THE CAMERA REPORT WAS ACCEPTABLE AND THE EVENT LOG INDICATED NO ERRORS AT TIME OF TESTING. ON APRIL 12, 2019 AN IMMUCOR FIELD SERVICE TECHNICIAN INSPECTED GALILEO ECHO V2 INSTRUMENT SERIAL NUMBER (B)(4) AT THE CUSTOMER FACILITY. THE TECHNICIAN FOUND THE INSTRUMENT OPERATIONAL AND PERFORMED A SUCCESSFUL UNEXPECTED REACTION CHECKLIST. FOUND CAMERA READER FOCUS WAS WITHIN SPECIFICATION, BUT NEEDED TO BE OPTIMIZED. RE-RAN SAMPLE IN QUESTION AFTER COMPLETION OF UNEXPECTED REACTIVITY CHECKLIST AND CAMERA READER OPTIMIZATION. SAMPLE RESULTED NEGATIVE. THE IMMUCOR INTERNAL REPORT RECORD NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE SCREEN RESULT WITH CAPTURE-R-READY-SCREEN 3 ON THE GALILEO ECHO V2 INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348724 GALILEO ECHO V2 AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. 10888234001584

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR