BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN

    MDR report key: 1080699 · Received July 25, 2008

    Report

    Report Number
    1034569-2008-00264
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 9, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REACTIVITY OF THE K ANTIGEN WAS CONFIRMED ON CAPTURE-R READY-SCREEN 4, LOT K182. THE CUSTOMER RETURNED SAMPLE FOR INVESTIGATION TESTING. THE SAMPLE WAS TESTED ON AN IN-HOUSE GALILEO WITH CRRS 4, LOT K182; NO REACTIVITY WAS OBSERVED. THE EVENTS APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS FOR CAPTURE-R READY SCREEN, ON A PATIENT SAMPLE KNOWN TO CONTAIN ANTI KELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. K182

    Patients

    Seq Age Sex Outcome Treatment
    1