BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SURGISCREEN

    MDR report key: 977403 · Received June 6, 2007

    Report

    Report Number
    2250051-2007-70289
    Event Type
    Malfunction
    Date Received
    June 6, 2007
    Date of Event
    May 7, 2007
    Report Date
    June 6, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PATIENT SAMPLE CONTAINING ANTI-FYB DID NOT REACT WITH CELL 3 OF SURGISCREEN LOT VSS104. SAMPLE REACTED WEAKLY WTIH CELL 2. CUSTOMER PERFORMED REPEAT TESTING AND BOTH CELLS WERE NONREACTIVE. PATIENT ALSE HAD A HISTORY OF ANTI-LEB, THERE WAS NO REACTIVITY SEEN WITH LEB POSITIVE CELLS (CELLS 1 AND 3). 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 VSS104

    Patients

    Seq Age Sex Outcome Treatment
    1 *