BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1222624 · Received November 10, 2008

    Report

    Report Number
    1034569-2008-00535
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 6, 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 D ANTIGEN WAS CONFIRMED WITH RETENTION CRRS(3), LOT R028 AND CRRID, LOT ID105. THESE REAGENTS WERE USED BY THE CUSTOMER AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON THE ECHO WITH CAPTURE-R READY ID. A PATIENT WITH A HISTORY OF AN ANTI-D RESULTED WITH A NEGATIVE SCREEN AND ID ON THE ECHO. THE ANTI-D WAS NOT RHIG INDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC. M00237

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR