BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN TEST WELLS

    MDR report key: 1070881 · Received July 9, 2008

    Report

    Report Number
    1034569-2008-00226
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 27, 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 OBSERVATIONS AND RESULTS WERE CONFIRMED. IT IS POSSIBLE THAT THE CAMERA READER LAMP DRIFTED IN INTENSITY AND/OR SPECTRUM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A PATIENT SAMPLE WITH A KNOWN ANTI-K. THE SAMPLE WAS TESTED ON THE GALILEO USING A 4 CELL SCREEN ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN TEST WELLS REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. K181

    Patients

    Seq Age Sex Outcome Treatment
    1