BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE R READY ID EXTEND

    MDR report key: 1050143 · Received May 27, 2008

    Report

    Report Number
    1034569-2008-00154
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 13, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CAPTURE READY-ID EXTEND AND CAPTURE-READY SCREEN 3 PACKAGE INSERTS, "PASSIVELY ADMINISTERED ANTI-D MAY FAIL TO REACT BY CAPTURE-R READY SCREEN, EVEN THOUGH THE ANTIBODIES ARE DETECTED BY AN ALTERNATIVE TECHNIQUE."

    Description of Event or Problem · 1

    CUSTOMER REPORTED CAPTURE R READY ID EXTEND II DID NOT PICK UP A PASSIVELY-AQUIRED ANTI-D. THE SAMPLE DID NOT REACT WITH THE ONE D+ CELL ON THE EXTEND II PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE R READY ID EXTEND REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. DN025

    Patients

    Seq Age Sex Outcome Treatment
    1