BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 4381530 · Received January 5, 2015

    Report

    Report Number
    1034569-2015-00004
    Event Type
    Malfunction
    Date Received
    January 5, 2015
    Date of Event
    December 9, 2014
    Report Date
    January 5, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE TEST WELL IMAGES ON THE ECHO: BATCH 74856 TESTED ON 07DEC2014 USING LOTS R520, 221269 NEGATIVE REACTIONS FOR ALL CELLS, VISUALLY NEGATIVE FOR CELLS 1 AND 3 (BOTH E-), VISUALLY POSITIVE FOR CELL 2 (E+) CUSTOMER COMMUNICATION CC (B)(4) ADVISES CUSTOMERS TO VISUALLY INSPECT ALL NEGATIVE RESULTS WITH CAPTURE-R READY-SCREEN ASSAYS ON THE ECHO.

    Description of Event or Problem · 1

    ON (B)(6) 2014 CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY-SCREEN 3 (B)(4) ON THE GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3717 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR