BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1187893 · Received October 8, 2008

    Report

    Report Number
    1034569-2008-00494
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 15, 2008
    Report Date
    October 2, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE D ANTIGEN WAS CONFIRMED ON RETENTION CRRS (3), LOT R027, AND CRRID, LOT ID104. THESE PRODUCTS WERE USED BY THE CUSTOMER AT THE TIME OF THE EVENT. TESTING WAS PERFORMED WITH THE CUSTOMER'S RETURNED PATIENT SAMPLE USING RETENTION CAPTURE-R READY-SCREEN (3), LOT R027, CAPTURE-R READY-ID, LOT ID104, AND CAPTURE-R INDICATOR RED CELLS, LOT 221252, ON AN IN-HOUSE ECHO. THE SAMPLE WAS NONREACTIVE IN ALL TESTING. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH THE CUSTOMER'S SAMPLE USING RETENTION PANOSCREEN I, II, AND III, LOT 32889. IMMUADD, LOT 6N5509, WAS USED AS POTENTIATOR. THE SAMPLE WAS NONREACTIVE (MACRO- AND MICRO-) WITH ALL CELLS TESTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WITH A PATIENT SAMPLE TESTED WITH CAPTURE-R READY ID (CRRID) ON THE ECHO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1