BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN

    MDR report key: 1233468 · Received November 19, 2008

    Report

    Report Number
    1034569-2008-00556
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 11, 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 CUSTOMER RERAN THE SAMPLE AND OBTAINED THE EXPECTED RESULTS. IT IS POSSIBLE THE INDICATOR CELLS WERE NOT AT CORRECT OPERATING TEMPERATURE. A SERVICE CALL WAS MADE. THE WASHER Z HEIGHT WAS ADJUSTED, TO REDUCE RESIDUAL VOLUME. THE INSTRUMENT PROCESSED SAMPLES, ALL RESULTS MET EXPECTATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH A HISTORY OF ANTI-KELL INITIALLY TESTED USING CAPTURE-R READY SCREEN (CRRS) 4 ON GALILEO, WITH NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. K193

    Patients

    Seq Age Sex Outcome Treatment
    1