BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 3585702 · Received January 21, 2014

    Report

    Report Number
    1034569-2014-00017
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    January 3, 2014
    Report Date
    January 15, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS IMAGES OF WELL RESULTS ON CUSTOMER INSTRUMENT ON (B)(4) 2014. NO PATIENT SAMPLE OR CUSTOMER PRODUCT WAS RETURNED TO IMMUCOR FOR IMMUCOR INVESTIGATION. AN IMMUCOR FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE ON (B)(4) 2014. THE FSE FOUND THE PROBE INTERNAL RINSE VOLUME TOO LOW, SO THE ASSOCIATED PERI-PUMP WAS ADJUSTED TO THE CORRECT VOLUME. THE SAMPLE IN QUESTION WAS THEN REPEATED FOR CAPTURE-R READY-SCREEN (3) WHICH YIELDED THE EXPECTED POSITIVE RESULT. THE FULL 510(K) NUMBER IS BK020053(1/27/03).

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED OBTAINING AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) ON GALILEO ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47442 CAPTURE-R READY INDICATOR RED CELLS ANTI-IGG COATED RED BLOOD CELLS KSZ IMMUCOR, INC. 221096

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR