BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISCREEN

    MDR report key: 1140483 · Received June 12, 2008

    Report

    Report Number
    2250051-2008-70300
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    April 14, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON THE EVENT DATE, CUSTOMER OBSERVED NO REACTIVITY WITH A PT SAMPLE CONTAINING ANTI-K AND 3SS788. THE FOLLOWING MONTH, A NEW PT SAMPLE WAS DRAWN AND USING A DIFFERENT LOT, 3SS801, A 1+ REACTION WAS OBSERVED. ADD'L TESTING WAS PERFORMED AND AN ANTI-KELL WAS IDENTIFIED. CUSTOMER WAS NOT ABLE TO REPEAT TESTING WITH 3SS788 SINCE PROD WAS NOW EXPIRED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGISCREEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS NA 3SS788

    Patients

    Seq Age Sex Outcome Treatment
    1 *