BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 1566048 · Received December 29, 2009

    Report

    Report Number
    1034569-2009-00466
    Event Type
    Malfunction
    Date Received
    December 29, 2009
    Date of Event
    December 4, 2009
    Report Date
    December 29, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TESTED RETURNED SAMPLE MANUALLY AND READ ON IN-HOUSE GALILEO USING RETENTION CRRS 3, LOT E017. WELL 1 (CW POS) = 8; WELL 2 (CW NEG) = 17; WELL 3 (CW NEG) = 8. ADDITIONALLY, THE RETURNED SAMPLE WAS TESTED BY MANUAL TUBE METHOD WITH RETENTION PANOSCREEN 3, CELL 1 (CW POS) AND THE RETURNED SAMPLE WAS NEGATIVE AT ALL PHASES OF TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED UNEXPECTED REACTION WHEN TESTING A SAMPLE ON THE ECHO WITH CAPTURE-R READY-SCREEN 3 (CRRS 3). THE ECHO SOFTWARE INTERPRETED A SAMPLE RESULT AS NEGATIVE, BUT VISUALLY THERE APPEARED TO BE A WEAK REACTION.

    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