BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2971679 · Received February 21, 2013

    Report

    Report Number
    1034569-2013-00042
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 21, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULT FILES WERE REVIEWED BY AN IMMUCOR TECHNICAL SUPPORT SPECIALIST. INITIAL TESTING RESULTS THAT RESULTED AS NEGATIVE WITH ALL CELLS VISUALLY APPEARED POSITIVE IN CELLS 1 AND 2. THE EXPECTED POSITIVE RESULTS WERE OBTAINED UPON REPEAT TESTING. 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 THE ANTIBODY SCREENING ASSAY ON GALILEO ECHO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75423 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR