BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (POOLED CELLS)

    MDR report key: 725147 · Received June 9, 2006

    Report

    Report Number
    1034569-2006-00024
    Event Type
    Malfunction
    Date Received
    June 9, 2006
    Date of Event
    January 4, 2005
    Report Date
    June 2, 2006
    Manufacturer
    IMMUCOR, INC.
    Product Code
    MWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING OF DONOR SAMPLE RECEIVED FROM CUSTOMER USING RETENTION PRODUCTS WAS PERFORMED. VERY WEAK REACTIVITY WAS DETECTED USING MANUAL TUBE AND MANUAL CAPTURE-R READY-SCREEN (POOLED CELLS) METHODS. TESTING USING CAPTURE-R READY-SCREEN (POOLED CELLS) ON AN AUTOMATED PLATFORM WAS NEGATIVE. THE LIMITATIONS SECTION OF THE PACKAGE INSERT FOR CAPTURE-R READY-SCREEN (POOLED CELLS) STATES, "ANTIBODY SCREENING TESTS EMPLOYING POOLED REAGENT RED CELLS WILL NOT BE AS SENSITIVE AS THOSE INCORPORATING THE RED CELLS OF UNPOOLED SINGLE DONORS." AND "NEGATIVE REACTIONS WILL BE OBTAINED IF THE TEST SPECIMENS CONTAIN ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHOD EMPLOYED." THE RESULTS APPEAR TO BE RELATED TO THE NATURE OF THE SAMPLE: THE CONCENTRATION OF THE ANTI-JKA ANTIBODY APPEARS TO BE AT OR BELOW THE THRESHOLD OF DETECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS TWO AUTOLOGOUS DONOR SAMPLES, FROM THE SAME DONOR, CONTAINING ANTI-JKA WERE NOT DETECTED; THE RED BLOOD CELLS WERE LABELED AS NEGATIVE FOR UNEXPECTED ANTIBODIES. UPON TESTING A SPECIMEN FROM THE PT BY THE HOSP, AN ANTI-JKA WAS DETECTED IN THE DONOR/PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN (POOLED CELLS) REAGENT RED BLOOD CELLS MWN IMMUCOR, INC. N042

    Patients

    Seq Age Sex Outcome Treatment
    1 YR