BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-B (MURINE MONOCLONAL) SERIES 3

    MDR report key: 1061890 · Received June 20, 2008

    Report

    Report Number
    1034569-2008-00195
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 17, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102692 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLES FOR INVESTIGATION TESTING. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS(4+) WITH ANTI-B, SERIES 3, LOT 203234 WHEN TESTING A PATIENT SAMPLE THAT PREVIOUSLY TYPED AS GROUP A. THIS HAS OCCURRED WITH OTHER PATIENT SAMPLES. NO TRANSFUSIONS OR ADVERSE REACTIONS OCCURRED AS A RESULT OF THE UNEXPECTED POSITIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-B (MURINE MONOCLONAL) SERIES 3 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 203234

    Patients

    Seq Age Sex Outcome Treatment
    1