BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN

    MDR report key: 808490 · Received January 10, 2007

    Report

    Report Number
    1034569-2007-00010
    Event Type
    Malfunction
    Date Received
    January 10, 2007
    Date of Event
    December 4, 2006
    Report Date
    January 10, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SENT PT SAMPLES FOR INVESTIGATION TESTING. TESTED PT SAMPLES WITH RETENTION CAPTURE-R READY-SCREEN (POOLED CELLS), LOT CW150. ONE PT SAMPLE SHOWED A 2+ POSITIVE REACTION; THE OTHER PT SAMPLE SHOWED A NTD RESULT. THE SAMPLES WERE ALSO TESTED BY TUBE METHOD WITH PANOSCREEN I, II, AND III REAGENT RED BLOOD CELLS USING IMMUADD AS THE POTENTIATOR. ONE SAMPLE, REPORTED TO CONTAIN ANTI-E, WAS NONREACTIVE AT ALL PHASES OF TESTING. THE OTHER SAMPLE, ONLY REACTED AT ROOM TEMPERATURE TESTING WITH CELL #2. FURTHER TESTING SHOWED THE ANTIBODY TO MOST LIKELY BE AN ANTI-P1. 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 CONTAINS ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHODS EMPLOYED".

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS FOR TWO PT SAMPLES WHEN TESTED WITH CAPTURE-R READY-SCREEN (POOLED CELLS), LOT CW150. ONE PT HAD A KNOWN ANTI-E. FOR THE OTHER PT, THE ANTIBODY COULD NOT BE IDENTIFIED BUT POSITIVE RESULTS WERE OBSERVED DURING TESTING WITH ANOTHER LOT OF PRODUCT, LOT CW155.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. * CW150

    Patients

    Seq Age Sex Outcome Treatment
    1 *