BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN TEST WELLS

    MDR report key: 1001587 · Received February 25, 2008

    Report

    Report Number
    1034569-2008-00028
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 8, 2008
    Report Date
    January 29, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S RETURNED SAMPLE, 5 IN-HOUSE DONOR SAMPLES AND A KNOWN ANTI-E POSITIVE SAMPLE WERE TESTED WITH RETENTION CAPTURE-R READY-SCREEN 4, LOT K160 ON AN IN-HOUSE GALILEO. THE IN-HOUSE DONOR SAMPLE AND KNOWN ANTI-E SAMPLE REACTED AS EXPECTED. THE RETURNED SAMPLE SHOWED A 4+ POSITIVE REACTION WITH CELL 2. THE RETURNED SAMPLE WAS TESTED AGAIN ON AN IN-HOUSE GALILEO WITH 4 IN-HOUSE DONOR SAMPLES USING RETENTION CRRS 4 LOT K160. THE IN-HOUSE DONOR SAMPLES REACTED AS EXPECTED. THE RETURNED SAMPLE AS NEGATIVE. THE EVENT APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT CAPTURE IV CELLS USED ON GALILEO MISSED AN ANTIE IN A PATIENT SAMPLE.

    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. K160

    Patients

    Seq Age Sex Outcome Treatment
    1