BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 9813230 · Received March 10, 2020

    Report

    Report Number
    1034569-2020-00019
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    February 13, 2020
    Report Date
    March 10, 2020
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001454
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020 IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO REVIEW TEST RECORDS FROM THE RELEVANT RUN ON THE ECHO LUMENA INSTRUMENT SERIAL NUMBER (B)(4). NO ERRORS WERE NOTED DURING PROCESSING. ON FEBRUARY 28, 2020 IMMUCOR CONFIRMED PRESENCE OF THE E ANTIGEN ON CELL #2 OF RETENTION CAPTURE-R READY-SCREEN 3 LOT R123 IN MANUAL CAPTURE USING RETENTION CAPTURE-R INDICATOR CELL 221498 WITH RETENTION ANTI-E LOT DL23523. CONTROLS PERFORMED AS EXPECTED. ALL E POSITIVE CELLS TESTED RESULTED POSITIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. THE IMMUCOR INTERNAL RECORD NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2020 A CUSTOMER REPORTED AN UNEXPECTED (B)(6) ANTIBODY SCREEN RESULT ON THE ECHO LUMENA INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277160 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R113 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR