BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (4)

    MDR report key: 785811 · Received November 13, 2006

    Report

    Report Number
    1034569-2006-00169
    Event Type
    Malfunction
    Date Received
    November 13, 2006
    Date of Event
    May 31, 2006
    Report Date
    November 13, 2006
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SUBMITTED TWO SAMPLES FROM THE PATIENT FOR INVESTIGATION TESTING. THE SAMPLES WERE TESTED WITH CAPTURE-R READY-SCREEN, LOT K094 ON AN IN-HOUSE GALILEO. ONE SAMPLE REACTED 1+ WITH CELL 3 AND THE SECOND SAMPLE WAS QUESTIONABLE WITH CELL 3. THE SAME SAMPLES WERE FURTHER TESTED WITH CAPTURE-R READY-SCREEN, LOT K093 AND WERE NEGATIVE. THE SAMPLES WERE TESTED WITH MANUAL TUBE METHOD USING PANOSCREEN, LOT 19183. 2+ TO 3+ REACTIVITY WAS SEEN AT THE ANTIGLOBULIN PHASE OF TESTING. ONE SAMPLE WAS TESTED WITH DIFFERENT ANTI-HUMAN GLOBULIN AND FYA+B- RED BLOOD CELLS. THE SAMPLE REACTED WITH ANTI-IGG, C3D, BUT WAS NON-REACTIVE WITH MONOCLONAL ANTI-IGG, -C3D AND MONOCLONAL ANTI-IGG SUGGESTING THE ANTIBODY IS PREDOMINATELY IGG4. THE LIMITATIONS SECTION OF THE CAPTURE-R READY-SCREEN (4) PACKAGE INSERT STATES: "EXAMPLES OF PURE IGG4 SUBCLASS ANTIBODIES MAY NOT BE DETECTED BY THE CAPTURE-R READY SCREEN INDICATOR RED CELLS REAGENT. NOTE, HOWEVER THAT PURE IGG4 ANTIBODIES ARE VERY UNCOMMON." THE EVENT APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN ON A PATIENT WITH A HISTORY OF ANTI-FY(A) WHEN TESTING WITH CAPTURE-R READY-SCREEN (4). THE ANTIBODY WAS DETECTED BY GEL METHODOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN (4) REAGENT RED BLOOD CELLS KSZ IMMUCOR * K094

    Patients

    Seq Age Sex Outcome Treatment
    1 *