BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2240522 · Received September 9, 2011

    Report

    Report Number
    1034569-2011-00133
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 12, 2011
    Report Date
    September 7, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK 070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE WELLS SHOWS THAT THE WELLS ARE (B)(6) IN APPEARANCE, BUT BEING INTERPRETED AS NEGATIVE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN 3 (CRRS 3) ON THE ECHO. THE SAMPLE WAS PREVIOUSLY TESTED ON THE ECHO AND RESULTED 3+ (B)(6) FOR ANTI-K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC. M00284

    Patients

    Seq Age Sex Outcome Treatment
    1