BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN

    MDR report key: 1202623 · Received October 21, 2008

    Report

    Report Number
    1034569-2008-00514
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 20, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT RETURN SAMPLE OR PRODUCT FOR INVESTIGATION. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A PATIENT SAMPLE TESTED ON GALILEO WITH CAPTURE-R READY SCREEN (CRRS). ANTI-FYA WAS NOT DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. K162

    Patients

    Seq Age Sex Outcome Treatment
    1