BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2545683 · Received April 24, 2012

    Report

    Report Number
    1034569-2012-00075
    Event Type
    Malfunction
    Date Received
    April 24, 2012
    Date of Event
    March 24, 2012
    Report Date
    April 24, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN IMMUCOR FIELD SERVICE ENGINEER PERFORMED THE UNEXPECTED REACTION CHECKLIST ON THE INSTRUMENT. THE MAIN PROBE WAS FOUND TO CONTAIN A CLOT. THE PROBE WAS CLEANED. QC AND WEAK D QC TESTING WERE PERFORMED AND BOTH TESTS PASSED. THE INSTRUMENT WAS TESTED AND PERFORMED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIONS WITH A CORD BLOOD SAMPLE WHEN TESTED ON ECHO INSTRUMENT (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO