BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 1961551 · Received January 14, 2011

    Report

    Report Number
    1034569-2011-00002
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 14, 2011
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL REVIEW OF THE BATCH FILES SHOWED CELL 1 AS BEING POSITIVE. THE CUSTOMER WAS REFERRED TO TECHNICAL COMMUNICATION (B)(4) WHICH RECOMMENDS THAT A VISUAL VERIFICATION BE PERFORMED ON ALL NEGATIVE REACTIONS ON THE ECHO INSTRUMENT BEFORE FINAL RELEASE OF RESULTS. THE 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 ECHO INSTRUMENT. THE CUSTOMER PERFORMED AN ANTIBODY SCREENING IN GEL AND OBTAINED POSITIVE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR