BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1373839 · Received May 5, 2009

    Report

    Report Number
    1034569-2009-00166
    Event Type
    Malfunction
    Date Received
    May 5, 2009
    Date of Event
    April 6, 2009
    Report Date
    May 4, 2009
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REACTIVITY OF THE E ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN(4) (CRRS(4)) LOT K213. THE REAGENT WAS USED AT THE TIME OF THE EVENT. THE REACTIVITY OF THE E ANTIGEN WAS CONFIRMED ON RETENTION PANOSCREEN III, LOT 08289. THE SUBMITTED SAMPLE, (HISTORY OF ANTI-E), WAS TESTED BY TUBE HEMAGGLUTINATION TEST METHOD WITH RETENTION PANOSCREEN III, LOT 08289 USING RETENTION IMMUADD LOT 7G5513 AS THE POTENTIATOR AND RETENTION ANTI-IGG, LOT MGG146-2. SAMPLE WAS NONREACTIVE WITH ALL THREE PANOSCREEN CELLS. THE RETURNED SAMPLE (HISTORY OF ANTI-E), WAS TESTED ON OUR IN-HOUSE GALILEO USING RETENTION CRRS(4), LOT K213. THE SAMPLE WAS NONREACTIVE WITH ALL FOUR CELLS. THE SAMPLE ANTIBODY APPEARS TO BE BELOW THE LEVEL OF DETECTION FOR CAPTURE ASSAYS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WITH 4 CELL SCREEN ON THE GALILEO WITH A PATIENT SAMPLE CONTAINING ANTI-E.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1