BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 730382 · Received June 20, 2006

    Report

    Report Number
    1034569-2006-00041
    Event Type
    Malfunction
    Date Received
    June 20, 2006
    Date of Event
    May 22, 2006
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT RETURN PRODUCT OR SPECIMENS FOR INVESTIGATION. TESTING PERFORMED ON THE RETENTION LOT OF CAPTURE-R READY-SCREEN (POOLED CELLS) CONFIRMED THE PRESENCE OF THE C, E, FYA, K, AND JKA ANTIGENS. THE LIMITATIONS SECTION OF THE PACKAGE INSERT FOR CAPTURE-R READY-SCREEN (POOLED CELLS) STATES, "ANTIBODY SCREENING TESTS EMPLOYING POOLED REAGENT RED CELLS WILL NOT BE AS SENSITIVE AS THOSE INCORPORATING THE RED CELLS OF UNPOOLED SINGLE DONORS" AND "NEGATIVE REACTIONS WILL BE OBTAINED IF THE TEST SPECIMENS CONTAIN ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHOD EMPLOYED." THE RESULTS APPEAR TO BE RELATED TO THE NATURE OF THE SAMPLES. THERE WAS NO TRANSFUSION OF INCOMPATIBLE BLOOD BASED ON THE RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 5 SAMPLES FROM PTS WITH KNOWN ANTIBODIES WERE REPORTED AS NEGATIVE BY THE GALILEO. THE SAMPLES TESTED POSITIVE USING A GEL METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO KSZ KSZ IMMUCOR, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *