BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2120121 · Received June 10, 2011

    Report

    Report Number
    1034569-2011-00066
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 10, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULT IMAGES IDENTIFIED THAT A BRIGHT AREA SEEN IN THE UPPER RIGHT CORNER ON ALL OF THE IMAGES. A SERVICE CALL WAS MADE. INVESTIGATION OF CUSTOMER COMPLAINT REVEALED ISSUES WITH CAMERA READER ASSEMBLY. REPLACED CAMERA READER ASSEMBLY. PERFORMED ALL CAMERA ALIGNMENTS AND CALIBRATIONS. PERFORMED QC TESTING WITH ACCEPTABLE RESULTS. CUSTOMER TESTED 4 SAMPLES WITH RFXGROUPSCREEN ASSAY WITH ACCEPTABLE RESULTS. SYSTEM IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN RH DISCREPANCY WHEN TESTING A PATIENT SAMPLE WITH THE WEAK D ASSAY ON THE ECHO. THE PATIENT IS HISTORICALLY A NEGATIVE. THE ECHO GENERATED NEGATIVE RESULTS FOR ANTI-D (MONOCLONAL BLEND) SERIES 4 AND ANTI-D (MONOCLONAL BLEND) SERIES 5. THE CUSTOMER PERFORMED WEAK D ON ECHO AND POSITIVE RESULT WAS GENERATED (4+). THE ECHO GENERATED NEGATIVE RESULTS FOR DAT. THE SAMPLE WAS TESTED BY MANUAL TUBE METHOD AND NEGATIVE RESULTS WERE GENERATED FOR DAT AND WEAK D.

    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