BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 3210822 · Received July 8, 2013

    Report

    Report Number
    1034569-2013-00120
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 8, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGE RESULT FILES FOR THE UNEXPECTED NEGATIVE REACTIVITY SHOWED THAT CELL 1 OF THE ANTIBODY SCREENING ASSAY RESULTED AS NEGATIVE AND VISUALLY APPEARED POSITIVE. THE CUSTOMER WAS MADE AWARE OF TECHNICAL COMMUNICATION (B)(4) WHICH ADVISES CUSTOMERS TO VISUALLY INSPECT ALL NEGATIVE ANTIBODY SCREENING AND IDENTIFICATION RESULTS ON THE ECHO PRIOR TO RELEASE OF RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIVITY WAS OBTAINED WITH A PATIENT'S SAMPLE ON GALILEO ECHO M01055.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309013 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR