BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 6515909 · Received April 24, 2017

    Report

    Report Number
    1034569-2017-00083
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    April 6, 2017
    Report Date
    April 24, 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 (1/27/03). THE PRODUCT HAD ALREADY EXPIRED AT THE TIME OF IMMUCOR'S RECEIPT OF THE EVENT INFORMATION. HOWEVER, THE IMMUCOR LABORATORY HAD PREVIOUSLY TESTED RETENTION PRODUCT ON 22MAR2017, WHICH HAD PERFORMED AS EXPECTED AT THAT TIME. IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE INSTRUMENT TEST WELL IMAGES IN QUESTION ON (B)(6) 2017, AND DETERMINED THAT THE INSTRUMENT TEST WELL IMAGE IN QUESTION WAS VISUALLY NEGATIVE, WITH A SLIGHT HAZE AROUND THE RED BLOOD CELL BUTTON.

    Description of Event or Problem · 1

    ON (B)(6) 2017, AN IMMUCOR EMPLOYEE PRESENT AT A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN 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
    296664 CAPTURE-R READY INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSF IMMUCOR, INC. 221820 10888234000600

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR