BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1063143 · Received June 24, 2008

    Report

    Report Number
    1034569-2008-00206
    Event Type
    Malfunction
    Date Received
    June 24, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 20, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED PATIENT SAMPLE WAS TESTED WITH RETENTION CRRS 3 LOT E006 ON AN IN-HOUSE ECHO. ANTI-K WAS DETECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON THE ECHO, FOR A PATIENT SAMPLE WITH A PREVIOUSLY IDENTIFIED ANTI-K.

    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