BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 7443111 · Received April 19, 2018

    Report

    Report Number
    1034569-2018-00099
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    March 26, 2018
    Report Date
    April 19, 2018
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSF
    UDI-DI
    10888234000600
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 27MAR2018 TO ASSESS THE INSTRUMENT TEST WELL IMAGES IN QUESTION WHICH APPEARED AS VISUALLY WEAK POSITIVE. THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON 28MAR2018, WHICH PERFORMED AS EXPECTED. COMPLAINTS OF POSITIVE REACTIONS BEING INTERPRETED AS NEGATIVE BY THE GALILEO ECHO CAMERA ALGORITHM ARE BEING CORRECTED UNDER DESIGN CONTROL PROJECT (B)(4). THE IMMUCOR TECHNICAL COMMUNICATION (B)(4) IS BEING USED BY THE LAB TO VISUALLY CONFIRM ALL NEGATIVE ASSAY EVENTS REPORTED BY THE ECHO INSTRUMENT. THE INTERNAL IMMUCOR (B)(4).

    Description of Event or Problem · 1

    ON 27MAR2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS BY GALILEO ECHO METHOD, WHEN TESTED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286911 CAPTURE-R READY INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSF IMMUCOR, INC. 221056 10888234000600

    Patients

    Seq Age Sex Outcome Treatment
    1