BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN

    MDR report key: 966678 · Received December 8, 2006

    Report

    Report Number
    2250051-2006-50538
    Event Type
    Malfunction
    Date Received
    December 8, 2006
    Date of Event
    May 15, 2006
    Report Date
    December 8, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN ANTIBODY SCREEN IN 2006 WAS NEGATIVE WITH 0.8% SELECTOGEN LOT 8S716, HOWEVER POST TRANSFUSION ANTI-E WAS IDENTIFIED. ANTIBODY SCREENS WERE PERFORMED ON THE EVENT DATE AND 10 DAYS LATER WITH LOT 8S716. NO REACTIVITY WAS OBSERVED. ABOUT TEN DAYS LATER, THE PT WAS TRANSFUSED WITH 1 UNIT OF PACKED RED BLOOD CELLS. APPROXIMATELY 2 MONTHS POST-TRANSFUSION TESTING OF PT'S SAMPLE WITH 8S724 WAS POSITIVE AND ANTI-E WAS IDENTIFIED. PT WAS DAT POSITIVE, NO ELUATE TEST WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SELECTOGEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS NA 8S716

    Patients

    Seq Age Sex Outcome Treatment
    1 *