BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SURGISCREEN

    MDR report key: 976664 · Received April 18, 2007

    Report

    Report Number
    2250051-2007-70179
    Event Type
    Malfunction
    Date Received
    April 18, 2007
    Date of Event
    March 22, 2007
    Report Date
    April 18, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PT'S SAMPLE CONTAINING ANTI-JKA DID NOT REACT WITH JKS POSITIVE CELLS OF 0.8% SURGISCREEN LOT 8SS473. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SURGISCREEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS NA 8SS473

    Patients

    Seq Age Sex Outcome Treatment
    1 *