BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1961533 · Received January 14, 2011

    Report

    Report Number
    1034569-2011-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 11, 2010
    Report Date
    January 14, 2011
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE EVENT LOG SHOWED NO ERRORS OCCURRED DURING THE TIME OF TESTING. UPON REVIEW OF THE BATCH FILES, ALL SCREENING CELLS APPEARED VISUALLY NEGATIVE WITH CELL 1 HAVING A VERY FAINT PINK ADHERENCE SURROUNDING THE CELL BUTTON. NO ADDITIONAL TESTING COULD BE PERFORMED DUE TO INSUFFICIENT SAMPLE VOLUME. A SERVICE TECHNICIAN REPLACED THE TUBING ON PROBES 1 AND 2, AND RE-TAUGHT THE LEFT PIPETTOR. THE DAILY QC WAS PERFORMED. SAMPLE RUNS PERFORMED AS EXPECTED. INSTRUMENT IS OPERATING AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN (CRRS) 3 ASSAY ON THE GALILEO INSTRUMENT. THE CUSTOMER PERFORMED AN ANTIBODY IDENTIFICATION PANEL AND OBTAINED POSITIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO BLOOD BANK ANALYZER KSZ IMMUCOR 10090

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR