BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1221491 · Received November 7, 2008

    Report

    Report Number
    1034569-2008-00534
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 3, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ABORH TESTING WAS PERFORMED WITH IN-HOUSE DONOR SAMPLES OF VARIOUS ABO/RH TYPES USING RETENTION ANTI-A, LOT 101682, ANTI-B SERIES 3, LOT 203235, A1 REFERENCELLS, LOT 111668, AND B REFERENCELLS, LOT 113668, ON AN IN-HOUSE ECHO. THESE REAGENTS WERE USED BY THE CUSTOMER AT THE TIME OF THE EVENT. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. NO ABO DISCREPANCY WAS OBSERVED. THE NATURE OF THE SAMPLE CAN NOT BE RULED OUT AS A CAUSE OF THE EVENT, BASED ON THE CUSTOMER'S TESTING, THE PATINET APPEARS TO BE AND ASUBB.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED REACTION ON THE ECHO. A PATIENT SAMPLE RESULTED AS B POSITIVE ON THE ECHO AND AB POSITIVE BY MANUAL TUBE TESTING.

    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 86 YR