BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R SELECT

    MDR report key: 3950037 · Received July 22, 2014

    Report

    Report Number
    1034569-2014-00127
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 22, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSS
    PMA / PMN Number
    BK040024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED REMOTE ELECTRONIC ACCESS METHOD TO ASSESS THE GALILEO ECHO ELECTRONIC IMAGES ON (B)(6) 2014. THE WELL IMAGES FOR THE UNEXPECTED CROSSMATCH COMPATIBLE WELLS ALL APPEARED AS UNEXPECTED NEGATIVE. THE UNEXPECTED CROSSMATCH COMPATIBLE RESULTS HAVE A POTENTIAL FOR A TRANSFUSION ERROR.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED UNEXPECTED COMPATIBLE CROSSMATCH RESULTS WHEN USING CAPTURE-R SELECT ON A GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428622 CAPTURE-R SELECT SOLID PHASE SYSTEM FOR THE IMMOBILIZATION OF HUMAN ERYTHROCYTES KSS IMMUCOR, INC. SC276

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR