BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 3863808 · Received June 10, 2014

    Report

    Report Number
    1034569-2014-00096
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 11, 2014
    Report Date
    June 9, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS INSTRUMENT TEST WELL IMAGES FOR THE SAMPLE ON (B)(6) 2014.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (POOLED CELLS) WITH A GALILEO INSTRUMENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341221 GALILEO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1