BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 7054455 · Received November 22, 2017

    Report

    Report Number
    1034569-2017-00321
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    October 12, 2017
    Report Date
    November 22, 2017
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSF
    UDI-DI
    10888234000594
    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). IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD ON (B)(4) 2017 TO ASSESS THE INSTRUMENT TEST WELL IMAGES IN QUESTION, AND DETERMINED THAT THE INSTRUMENT TEST WELL IMAGES IN QUESTION WERE VISUALLY NEGATIVE. THE IMMUCOR LABORATORY HAD PREVIOUSLY TESTED RETENTION PRODUCT ON (B)(4) 2017 WHICH HAD PERFORMED AS EXPECTED. AT THE TIME OF THE CUSTOMER COMPLAINT, THE PRODUCT WAS ALREADY EXPIRED.

    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, WHEN TESTED ON (B)(6) 2017. A SUBSEQUENT BLOOD SAMPLE ((B)(6)) FOR THE SAME PATIENT ALSO YIELDED AN UNEXPECTED NEGATIVE SCREEN OUTCOME WHEN TESTED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834045 CAPTURE-R READY INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSF IMMUCOR, INC. 221947 10888234000594

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR