BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 774071 · Received August 23, 2006

    Report

    Report Number
    1034569-2006-00084
    Event Type
    Malfunction
    Date Received
    August 23, 2006
    Date of Event
    July 25, 2006
    Report Date
    August 23, 2006
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    bk040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE CUSTOMER SAMPLE REPORTED TO HAVE ANTI-JKA WAS SENT FOR INVESTIGATION. THE PRESENCE OF THE E AND JKA ANTIGENS WERE CONFIRMED ON CAPTURE-R READY-ID, LOT ID073. TESTING WAS PERFORMED WITH THE CUSTOMER'S SAMPLE USING RETENTION CAPTURE-R REASY-ID, LOT ID073 AND CAPTURE-R INDICATOR RED CELLS, LOT 221897; THE SAMPLE WAS NONREACTIVE WITH ALL CELLS TESTED. IN-HOUSE DONOR SAMPLES AND THE CUSTOMER'S SUBMITTED SAMPLE WERE TESTED ON AN IN-HOUSE GALILEO. THE IN-HOUSE DONOR SAMPLES WERE NONREACTIVE, AS EXPECTED. THE CUSTOMER'S SAMPLE WAS REACTIVE. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH CUSTOMER'S SAMPLE USING RETENTION PANOSCREEN, LOT 23248. THE SAMPLE EXHIBITED 1+ MACROSCOPIC REACTIVITY WITH JK (A+B-) CELLS, WEAK MACROSCOPIC REACTIVITY WITH JK (A+B+) CELLS AND WAS NONREACTIVE WITH JK (A-) CELLS. THE GALILEO OPERATORS MANUAL STATES, "THE GALILEO CANNOT RELIABLY DETECT HEMAGGLUTINATION REACTIONS THAT ARE GRADED AS 1+ OR LESS IN TEST TUBE METHODOLOGY." THE CUSTOMER'S COMPLAINT APPEAR TO BE RELATED TO THE NATURE OF THE SPECIMEN USED FOR TESTING. ALTHOUGH A TRANSFUSION OF INCOMPATIBLE BLOOD DID NOT OCCUR, THE POTENTIAL FOR TRANSFUSION OF INCOMPATIBLE BLOOD EXISTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MISSED ANTIBODIES ON THE GALILEO INSTRUMENT. TWO SAMPLES FROM DIFFERENT PTS HAD ANTI-JKA AND ANTI-E, RESPECTIVELY, WHICH WERE NOT DETECTED BY THE GALILEO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * CAPTURE-R INDICATOR RED CELLS, LOT 221897| CAPTURE-R READY-ID, LOT ID073