BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 8439737 · Received March 21, 2019

    Report

    Report Number
    1034569-2019-00062
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 21, 2019
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001454
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD ON (B)(6) 2019 TO ASSESS THE TESTING INSTRUMENT IN QUESTION. THE CAMERA REPORT APPEARED ACCEPTABLE, AND NO INSTRUMENT ERRORS WERE NOTED AROUND THE TIME THAT THE TESTING WAS PERFORMED. THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON (B)(6) 2019, WHICH PERFORMED AS EXPECTED. THE IMMUCOR LABORATORY ALSO RECEIVED A BLOOD SAMPLE FROM THE CUSTOMER SITE (F19980) AND TESTED IT AGAINST RETENTION PRODUCT OF R038 AND 221273, WHICH YIELDED AN EQUIVOCAL OUTCOME. AN IMMUCOR FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE ON (B)(6) 2019 TO ASSESS THE TESTING INSTRUMENT IN QUESTION, WHICH PERFORMED AS EXPECTED. THE INTERNAL IMMUCOR DOCUMENT NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233612 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R038 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR