BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 920343 · Received October 1, 2007

    Report

    Report Number
    1034569-2007-00227
    Event Type
    Malfunction
    Date Received
    October 1, 2007
    Date of Event
    August 17, 2007
    Report Date
    September 13, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE JKA ANTIGEN WAS CONFIRMED ON RETURNED AND RETENTION CAPTURE-R READY-SCREEN (I AND II), LOT X206 WITH ANTI-JKA, LOT QC#3 (DILUTED 1:32) USING CAPTURE-R INDICATOR RED CELLS, LOT 221049 BY CALIBRATED METHOD. THE 2_CELL TESTING WAS PERFORMED WITH RETENTION CAPTURE-R READY-SCREEN (I AND II), LOT X206 AND CAPTURE-R INDICATOR RED CELLS, LOT 221049 USING IN-HOUSE DONOR SAMPLES AND CUSTOMER'S PATIENT SAMPLES ON AN IN-HOUSE GALILEO. THE RETURNED SAMPLES AND IN-HOUSE DONOR SAMPLES WERE NONREACTIVE IN ALL TESTING. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH CUSTOMER'S PATIENT'S SAMPLES USING CELL I [JK(A-)] AND CELL II [JK(A+B+)] FROM RETENTION PANOSCREEN I, II, AND III. IMMUADD WAS USED AS POTENTIATOR. THE PATIENT SAMPLES WERE NONREACTIVE WITH CELL I AND EXHIBITED VERY WEAK POSITIVE MICROSCOPIC REACTIVITY WITH CELL II AT IAT PHASE. CALIBRATED MANUAL TESTING PERFORMED WITH RETENTION CAPTURE-R READY-SCREEN (4), LOT K148 AND CAPTURE-R INDICATOR RED CELLS, LOT 221049 USING CUSTOMER'S PATIENT'S SAMPLES. ONE SAMPLE EXHIBITED MODERATE POSITIVE REACTIVITY WITH JK(A+B-) CELLS, WEAK POSITIVE REACTIVITY WITH JK(A+B+) CELL. SAMPLES APPEAR TO HAVE WEAK AND VARIABLE REACTIVITY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MISSED ANTIBODY USING THE 2 CELL SCREEN ASSAY ON THE GALILEO. A PATIENT SAMPLE WAS INITIALLY TESTED IN 2007; NEGATIVE ANTIBODY SCREEN RESULTS WERE GENERATED ON THE GALILEO. THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF BLOOD ON THE SAME DAY, ANTIGEN STATUS UNKNOWN. A SAMPLE FROM THE SAME PATIENT WAS TESTED ON FOUR DAYS LATER; A NEGATIVE ANTIBODY SCREEN RESULTED ON THE GALILEO. THE PATIENT WAS TRANSFUSED WITH 2 UNITS AND ONE UNIT WAS JKA POSITIVE. ANOTHER SAMPLE FROM THIS PATIENT WAS TESTED ON SIX DAYS LATER; ANTIBODY SCREEN WAS POSITIVE ON THE GALILEO. THE SAMPLES FROM ORIGINAL DATE AND FOUR DAYS LATER, WERE RETESTED; POSITIVE REACTIONS WERE OBSERVED. POSITIVE REACTIONS WERE ALSO OBSERVED WITH THOSE SAMPLES USING TUBE TESTING WITH PEG AS AN ENHANCEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1