BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-B(MURINE MONOCLONAL) SERIES 3

    MDR report key: 1025161 · Received April 8, 2008

    Report

    Report Number
    1034569-2008-00101
    Event Type
    Malfunction
    Date Received
    April 8, 2008
    Date of Event
    March 21, 2008
    Report Date
    April 4, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102692 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH RETURNED AND RETENTION ANTI-B SERIES 3, LOT 203231, USING RETURNED AND RETENTION A1 REFERENCELLS, LOT 111638, AND B REFERENCELLS, LOT 113638. CELL #20 FROM RETENTION PANOCELL-20, LOT 04478, WAS USED AS O CELL. ALL PRODUCTS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY ARE GETTING UNEXPECTED POSITIVE REACTIONS WITH ANTI-B (MURINE MONOCLONAL) SERIES 3, LOT #203231 WHEN TESTING WITH A1 CELLS, LOT#111638, EXP. 4/04/08, DURING QC. METHODOLOGY IS TUBE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-B(MURINE MONOCLONAL) SERIES 3 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 203231

    Patients

    Seq Age Sex Outcome Treatment
    1