BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN

    MDR report key: 1173746 · Received September 25, 2008

    Report

    Report Number
    1034569-2008-00476
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 25, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE INSTRUMENT IMAGES WAS FOUND TO BE CONSISTENT WITH THE GALILEO INTERPRETIONS. THE PACKAGE INSERT FOR CAPTURE INDICATES THAT PASSIVELY ADMINISTERED ANTI-D MAY FAIL TO REACT WITH CAPTURE, ALTHOUGH IT MAY BE DETECTED BY AN ALTERNATIVE TECHNIQUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT SAMPLE TESTED WITH CAPTURE-R READY SCREEN (CRRS) PRODUCED UNEXPECTED NEGATIVE REACTIONS ON GALILEO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR