BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1392138 · Received May 22, 2009

    Report

    Report Number
    1034569-2009-00181
    Event Type
    Malfunction
    Date Received
    May 22, 2009
    Date of Event
    April 29, 2009
    Report Date
    May 20, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE C, E, AND JKB ANTIGENS WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN (CRRS) (I AND II), LOT X282, AND CRRID EXTEND I, LOT DP034. THESE LOTS WERE USED BY THE CUSTOMER AT THE TIME OF THE EVENT. REACTIVITY OF THE E ANTIGEN WAS CONFIRMED ON RETENTION CRRID ID USED BY THE CUSTOMER AT THE TIME OF THE EVENT. REACTIVITY OF THE C AND JKB ANTIGENS WAS CONFIRMED BY DHR REVIEW; THE RETENTION REAGENT WAS DEPLETED. REACTIVITY OF THE C, E, AND JKB ANTIGENS WAS CONFIRMED ON RETURNED CRRS (I AND II), LOT X282, AND RETURNED CRRID EXTEND I, LOT DP034. RETURNED AND RETENTION CRRS(I/II), LOT X282 WERE TESTED WITH CUSTOMER'S RETURNED SAMPLE. THE SAMPLE DEMONSTRATED POSITIVE (1+) REACTIVITY WITH CELL II (JK(B+)) OF THE RETURNED PRODUCT. THE SAMPLE WAS NONREACTIVE WITH RETENTION LOT X282. THE SAMPLE WAS TESTED WITH THE RETURNED AND RETENTION CRRID LOT, DP034. THE SAMPLE DEMONSTRATED POSITIVE REACTIVITY (2+) WITH CELL 14 (C+E+JKB+) OF THE RETURNED LOT. THE SAMPLE WAS NONREACTIVE WITH THE RETENTION LOT, DP034. THE SAMPLE WAS TESTED BY TUBE HEMAGGLUTINATION TEST METHOD WITH SELECTED C-E-JK(B-), C-E-JK(B+), C+E-JK(B-) AND C-E+JK(B-) REAGENT RED BLOOD CELLS USING IMMUADD AS THE POTENTIATOR. TWO TESTING PARAMETERS WERE PERFORMED: 1) SAMPLE TESTED AT IMMEDIATE SPIN (IS) AND ROOM TEMPERATURE (RT); 2) SAMPLE TESTED AT 37C AND INDIRECT ANTIGLOBULIN TEST PHASE. THE SAMPLE DEMONSTRATED POSITIVE (1+) REACTIVITY AT THE RT AND IAT PHASES. THE NATURE OF THE SAMPLE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A PATIENT SAMPLE TESTED BY THE 2_CELL SCREEN ASSAY ON GALILEO. PATIENT'S HISTORICALLY KNOWN ANTIBODIES INCLUDE ANTI-C, ANTI-E, ANTI-JKB.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR