BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 7545105 · Received May 25, 2018

    Report

    Report Number
    1034569-2018-00127
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 25, 2018
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSF
    UDI-DI
    10888234000600
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 TO ASSESS THE INSTRUMENT TEST WELL IMAGES IN QUESTION ON 01MAY2018, WHICH VISUALLY APPEARED POSITIVE. A REVIEW OF THE CHECK IMAGE WELL SHOWED A BUBBLE IN THE 3RD SCREENING WELL, AND THE EVENT LOG SHOWED THAT THERE WAS A WARNING FOR THE REAGENT IN QUESTION OF A REMAINING LIQUID VOLUME LOWER THAN EXPECTED. THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON 17MAY2018 AND 21MAY2018 AGAINST ANTIBODY SCREEN STRIP R969, 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 ECHO INSTRUMENT IS PERFORMING AS EXPECTED WITH THE EXCEPTION OF THE CAMERA MODULE ABILITY TO APPROPRIATELY IDENTIFY SOME TRUE POSITIVE RESULTS. THE IMMUCOR TECHNICAL COMMUNICATION (B)(4) IS BEING USED BY THE LAB TO VISUALLY CONFIRM ALL NEGATIVE ASSAY EVENTS REPORTED BY THE ECHO INSTRUMENT. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388006 CAPTURE-R READY INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSF IMMUCOR, INC. 221081 10888234000600

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR