BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1252743 · Received December 9, 2008

    Report

    Report Number
    1034569-2008-00583
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    November 12, 2008
    Report Date
    December 2, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE E ANTIGEN WAS CONFIRMED ON RETENTION CRRS (3), LOT R031, USED BY THE CUSTOMER AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCREPANT RESULTS ON THE ECHO. CUSTOMER WAS PERFORMING ECHO VALIDATION AND OBSERVED DISCREPANT RESULTS WITH THE ECHO VERSUS TUBE TESTING. A PATIENT SPECIMEN WITH A HISTORY OF ANTI-E TESTED ON THE ECHO, RESULTED AS NEGATIVE WITH CAPTURE-R READY SCREEN (CRRS)3, AND MICROSCOPIC POSITIVE WITH TUBE TESTING USING N-HANCE.

    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