BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 3944517 · Received July 18, 2014

    Report

    Report Number
    1034569-2014-00122
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 18, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR LABORATORY IN (B)(4) TESTED RETENTION PRODUCT ON (B)(4) 2014 USING ANTI-FYB REAGENT ANTISERUM WHICH PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A (B)(6) 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
    421530 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. J054

    Patients

    Seq Age Sex Outcome Treatment
    1