BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID

    MDR report key: 1222626 · Received November 10, 2008

    Report

    Report Number
    1034569-2008-00547
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 6, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REACTIVITY OF THE FYB ANTIGEN WAS CONFIRMED ON RETENTION CRRID, LOT ID104. THE CUSTOMER RETURNED SAMPLE FOR INVESTIGATION TESTING. NO REACTIVITY WAS OBSERVED WITH THE SAMPLE WHEN TESTED ON AN IN-HOUSE GALILEO. THE NATURE OF THE SAMPLE APPEARS TO BE THE CAUSED OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A KNOWN ANTI-FY(B) WAS NOT FOUND ON A PATIENT SAMPLE TESTED WITH CAPTURE-R READY ID (CRRID).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID 104

    Patients

    Seq Age Sex Outcome Treatment
    1