BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1253493 · Received December 9, 2008

    Report

    Report Number
    1034569-2008-00579
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    November 11, 2008
    Report Date
    December 1, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE K ANTIGEN WAS CONFIRMED ON RETENTION CRRS (3), LOT R028, USED BY THE CUSTOMER AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A PATIENT SAMPLE CONTAINING ANTI-K, ON THE ECHO.NO TRANSFUSIONS OR ADVERSE REACTIONS OCCURRED AS A RESULT OF THE UNEXPECTED NEGATIVE REACTIONS.

    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 55 YR