BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-A (MURINE MONOCLONAL) SERIES 1

    MDR report key: 1025160 · Received April 8, 2008

    Report

    Report Number
    1034569-2008-00102
    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
    102691 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 RETENTION ANTI-A, LOT 101676, USING 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.HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH RETURNED ANTI-A, LOT 101676, 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 REPORTED UNEXPECTED POSITIVE REACTIONS (GRAINY) WITH ANTI-A(MURINE MONOCLONAL) SERIES 1, LOT #101676, EXP. 7/18/09 WHEN TESTING WITH B CELLS, LOT #113638, EXP. 4/04/08 DURING DAILY QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-A (MURINE MONOCLONAL) SERIES 1 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 101676

    Patients

    Seq Age Sex Outcome Treatment
    1