BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (I AND II)

    MDR report key: 7046850 · Received November 20, 2017

    Report

    Report Number
    1034569-2017-00315
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    October 26, 2017
    Report Date
    November 20, 2017
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234000648
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLICATED PRODUCT HAD A DHR REVIEW ON (B)(6) 2017 FOR INFORMATION REGARDING LEB ANTIGEN REACTIVITY, AND IT WAS DETERMINED THAT THE PRESENCE OF LEB ANTIGEN WAS CONFIRMED IN BULK TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2017, AN IMMUCOR EMPLOYEE VISITING A CUSTOMER SITE, REPORTED ON BEHALF OF THE CUSTOMER AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826407 CAPTURE-R READY-SCREEN (I AND II) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. X473 10888234000648

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR