BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID

    MDR report key: 1222623 · Received November 10, 2008

    Report

    Report Number
    1034569-2008-00525
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 13, 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
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACKAGE INSERT FOR CAPTURE CONTAINS A LIMITATION THAT PASSIVELY ADMINISTERED ANTI-D MAY FAIL TO REACT BY CAPTURE, EVEN THOUGH THE ANTIBODY CAN BE DETECTED BY AN ALTERNATIVE TECHNIQUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVES ON CAPTURE-R READY ID (CRRID) FOR A PRENATAL PATIENT THAT HAD AN ACQUIRED D BY ADMINISTRATION OF RHOGAM. ANTIBODY SCREEN ON THE ECHO WAS POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID106

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR