BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 6471958 · Received April 7, 2017

    Report

    Report Number
    1034569-2017-00070
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    March 26, 2017
    Report Date
    April 7, 2017
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSF
    UDI-DI
    10888234000600
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL NUMBER FOR THE PRODUCT IN QUESTION IS BK020053 (1/27/2003). THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON 03APR2017, WHICH PERFORMED AS EXPECTED. IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE INSTRUMENT TEST WELL IMAGES IN QUESTION ON 28MAR2017, AND DETERMINED THAT THE INSTRUMENT TEST WELL IMAGES IN QUESTION WERE VISUALLY NEGATIVE. AN IMMUCOR FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO ASSESS THE TESTING INSTRUMENT ON 28MAR2017. THE FSE REPLACED THE REAGENT PROBE ASSEMBLY.

    Description of Event or Problem · 1

    ON 27MAR2017, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253589 CAPTURE-R READY INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSF IMMUCOR, INC. 221824 10888234000600

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR