BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN

    MDR report key: 1113743 · Received June 10, 2008

    Report

    Report Number
    2250051-2008-70265
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    May 12, 2008
    Report Date
    June 10, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTING NO REACTIVITY WITH A PT SAMPLE CONFIRMED TO HAVE AN ANTI-JK(B) AGAINST VS185. THE CUSTOMER INDICATED THAT THE SAMPLE SHOWED A 2+ REACTION AGAINST VS185 CELL I (FAY+B-, JKA-B+). THE SAMPLE WAS TESTED AGAINST VRA115. THE FAY+B- CELLS REACTED (2+). THE SAMPLE WAS SENT TO THEIR REFERENCE LABORATORY. THE CUSTOMER REPORTS THAT ANTI-FY(A) AND ANTI-JK(B) WERE IDENTIFIED USING PEG AS AN ENHANCEMENT. CUSTOMER STATED NO REPORTS OF ANY DISCREPANCIES WITH ANY OTHER PTS OR WITH QC TESTING. NO ERRONEOUS RESULTS WERE REPORTED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SELECTOGEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS NA VS185

    Patients

    Seq Age Sex Outcome Treatment
    1 *