BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1070876 · Received July 9, 2008

    Report

    Report Number
    1034569-2008-00242
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 13, 2008
    Report Date
    July 2, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN SAMPLES OR PRODUCT. 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 ON THE ECHO FOR A PATIENT SAMPLE KNOWN TO CONTAIN ANTI-E. TESTING WITH CAPTURE-R READY SCREEN (3) PERFORMED ON THE ECHO WAS NEGATIVE.

    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 63 YR