BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 3920117 · Received July 8, 2014

    Report

    Report Number
    1034569-2014-00111
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    July 8, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE INSTRUMENT TEST WELL IMAGES ON (B)(4) 2014. IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON (B)(4) 2014 WHICH PERFORMED AS EXPECTED. THE CUSTOMER COULD NOT RETURN ANY SITE BLOOD SAMPLES OR TESTING PRODUCT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397765 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R411

    Patients

    Seq Age Sex Outcome Treatment
    1