BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 3635311 · Received February 19, 2014

    Report

    Report Number
    1034569-2014-00024
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 24, 2014
    Report Date
    February 18, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. THE FULL PMA/510(K) NUMBER IS BK02005.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105119 CAPTURE-R READY INDICATOR RED CELLS ANTI-IGG COATED RED BLOOD CELLS KSZ IMMUCOR, INC. 221108

    Patients

    Seq Age Sex Outcome Treatment
    1