BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN (POOLED CELLS)

    MDR report key: 1074484 · Received July 15, 2008

    Report

    Report Number
    1034569-2008-00257
    Event Type
    Malfunction
    Date Received
    July 15, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 7, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH CUSTOMER'S RETURNED SAMPLE (3+-4+ HEMOLYSIS) USING SELECTED LE(A+) AND LE(A-) CELLS FROM RETENTION PANOCELL-10, LOT 17683. IMMUADD, LOT 7G5513 WAS USED AS POTENTIATOR. SAMPLE EXHIBITED NEGATIVE TO +W REACTIVITY AT ALL TEMPERATURES, INCLUDING IAT, WITH LE(A+) CELLS; LE(A-) CELL WAS NONREACTIVE. THE SAMPLE COULD NOT BE TESTED WITH CAPTURE-R READY SCREEN DUE TO THE HEMOLYSIS PRESENT. THE LIMITATIONS SECTION OF THE PACKAGE INSERT STATES: "ANTIBODY SCREENING TESTS EMPLOYING POOLED REAGENT RED BLOOD CELLS WILL NOT BE AS SENSITIVE AS THOSE INCORPORATING THE RED BLOOD CELLS OF UNPOOLED SINGLE DONORS."

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ANTI-LEA WAS NOT DETECTED ON THE GALILEO WHEN PERFORMING ANTIBODY SCREEN WITH CAPTURE-R READY SCREEN (POOLED CELLS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN (POOLED CELLS) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. N154

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR