BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2072870 · Received April 29, 2011

    Report

    Report Number
    1034569-2011-00049
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 29, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT MAINTENANCE WAS UP TO DATE AND CAMERA CALIBRATION VALUES WERE WITHIN THE EXPECTED RANGE. AN IMMUCOR SERVICE TECHNICIAN PERFORMED THE UNEXPECTED REACTION CHECKLIST. ALL SETTINGS WERE WITHIN SPECIFICATION. A SLIGHT ADJUSTMENT WAS MADE TO THE ROBOT HANDLER Y BELT. THE CUSTOMER DID NOT HAVE ENOUGH SAMPLE REMAINING FOR ADDITIONAL TESTING. THE QC ASSAY WAS PERFORMED. THE INSTRUMENT IS OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH THE SCREENING ASSAY ON THE GALILEO ECHO INSTRUMENT.

    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 23 YR