BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2844352 · Received November 26, 2012

    Report

    Report Number
    1034569-2012-00220
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 26, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMAGE RESULT FILES WERE REVIEWED BY AN IMMUCOR TECHNICAL SUPPORT SPECIALIST. WELL IMAGES SHOWED ONLY THE NEGATIVE CONTROL TO HAVE A TIGHT CELL BUTTON. ALL OTHER WELLS HAD A FUZZIER BUTTON WITH VERY SLIGHT RED CELL ADHERENCE TO THE MONOLAYER. POSITIVE CONTROL APPEARED AS EXPECTED WITH REACTION STRENGTH 100. REACTION STRENGTHS FOR REPORTED NEGATIVES WERE GRADED AT 0. AN IMMUCOR FIELD SERVICE ENGINEER CLEANED CAMERA MIRROR; CALIBRATED CAMERA FOCUS AND GAIN AND CALIBRATED RESIDUAL VOLUME. THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN UNEXPECTED NEGATIVE REACTION WAS OBTAINED ON GALILEO 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 74 YR