BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 1781121 · Received August 3, 2010

    Report

    Report Number
    1034569-2010-00178
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 29, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK 070016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT RESULTS: CRRS3 (LOT R093) NEGATIVE WITH CELLS 1-3, 4+ POSITIVE CONTROL. WELL IMAGES OF CELLS 1 AND 3 DISPLAYED A TIGHT BUTTON WITH A LIGHT PINK BACKGROUND. CELLS 1 AND 3 ARE FYB+. CRRID WAS NON REACTIVE WITH CELL 1 AND CELLS 3-14, EQUIVOCAL WITH CELL 2 (CUSTOMER EDITED TO NEGATIVE, WELL IMAGE A TIGHT BUTTON WITH A LIGHT PINK BACK GROUND). CELLS 1,2,3, 6, 8,12, 13, AND 14 ARE FYB +. IMAGES OF WELLS 6, 8, 12, 13, 14 DISPLAYED TIGHT BUTTONS WITH A LIGHT PINK BACKGROUND. A SERVICE CALL WAS MADE. EVALUATION OF UNIT PERFORMANCE REVEALED NO ABNORMALITIES. SYSTEM TESTED AND FOUND TO BE OPERATING WITHIN SPECIFICATIONS WITH NO PROBLEMS OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN 3 (CRRS3) AND CAPTURE-R READY ID (CRRID) ON THE ECHO. THE PATIENT HAS A HISTORY OF AN ANTI-FYB. THE SAMPLE WAS RE-TESTED ON THE ECHO AND RESULTED AS 3+ POSITIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR