BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 6575970 · Received May 18, 2017

    Report

    Report Number
    1034569-2017-00098
    Event Type
    Malfunction
    Date Received
    May 18, 2017
    Date of Event
    May 4, 2017
    Report Date
    May 18, 2017
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSF
    UDI-DI
    10888234000600
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL NUMBER FOR THE PRODUCT IN QUESTION IS BK020053 (1/27/03). THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON 11MAY2017, WHICH PERFORMED AS EXPECTED. IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE INSTRUMENT TEST WELL IMAGE IN QUESTION ON (B)(6) 2017, AND DETERMINED THAT THE INSTRUMENT TEST WELL IMAGE IN QUESTION WAS VISUALLY NEGATIVE, WITH NO RED BLOOD CELL ADHERENCE. AN IMMUCOR FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE ON 05MAY2017 TO ASSESS THE TESTING INSTRUMENT AND FOUND THE INSTRUMENT TO BE OPERATING AS EXPECTED. THE FSE PROACTIVELY REPLACED THE INSTRUMENT SYRINGES.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357675 CAPTURE-R READY INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSF IMMUCOR, INC. 221842 10888234000600

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR