BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 6686380 · Received July 5, 2017

    Report

    Report Number
    1034569-2017-00126
    Event Type
    Malfunction
    Date Received
    July 5, 2017
    Date of Event
    May 19, 2017
    Report Date
    July 5, 2017
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSF
    UDI-DI
    10888234000600
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL NUMBER FOR THE PRODUCT IN QUESTION IS BK020053 (1/27/03). THE PRODUCT HAD ALREADY EXPIRED WHEN THE CUSTOMER CALLED TO REPORT THE EVENT, BUT THE IMMUCOR LABORATORY PERFORMED A DHR REVIEW ON 15JUN2017, WHICH SHOWED THAT THE PRODUCT WAS ACCEPTABLE BEFORE THE PRODUCT WAS RELEASED TO MARKET. IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD ON (B)(6) 2017 TO ASSESS THE INSTRUMENT TEST WELL IMAGES IN QUESTION, AND DETERMINED THAT THE INSTRUMENT TEST WELL IMAGES IN QUESTION WERE VISUALLY NEGATIVE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465998 CAPTURE-R READY INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSF IMMUCOR, INC. 221859 10888234000600

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR