BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN I AND II

    MDR report key: 2792669 · Received October 16, 2012

    Report

    Report Number
    1034569-2012-00194
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 9, 2012
    Report Date
    October 16, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE IMAGE RESULT FILES, THE ANTIBODY SCREENING AND IDENTIFICATION RESULTS APPEARED AS REPORTED BY THE NEO. NEGATIVE RESULTS WERE OBTAINED WITH E POSITIVE CELLS IN THE SCREENING ASSAY AND VISUALLY APPEARED NEGATIVE. CONTROLS REACTED AS EXPECTED. THE ANTIBODY IDENTIFICATION ASSAY WAS PERFORMED AND E POSITIVE CELLS RESULTED AS EQUIVOCAL (CELL 1) AND NEGATIVE (CELL 3 AND CELL 6). RESULTS VISUALLY APPEARED AS EXPECTED. THE CUSTOMER WAS REFERRED TO THE LIMITATION SECTION OF THE PACKAGE INSERT, WHICH STATES: "NEGATIVE REACTIONS WILL BE OBTAINED IF THE TEST SPECIMEN CONTAINS ANTIBODIES PRESENT IN CONCENTRATION TOO LOW TO BE DETECTED BY THE TEST METHODS EMPLOYED."

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIONS WERE OBTAINED WITH THE 2-CELL SCREEN (LOT X367) ON THE GALILEO NEO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN I AND II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. X367

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR