BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 1053864 · Received June 2, 2008

    Report

    Report Number
    1034569-2008-00165
    Event Type
    Malfunction
    Date Received
    June 2, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 19, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE FYA ANTIGEN WAS CONFIRMED ON RETENTION CRRS(3), LOT R022 AND CRRID, LOT ID100, AND ALSO ON RETURNED CRRS(3), LOT R022. THE RETURNED PATIENT'S SAMPLES ( FROM THE SAME PATIENT BUT COLLECTED ON DIFFERENT DATES) WERE TESTED WITH RETENTION CRRS(3), LOT R022 AND SELECTED FY(A+B+), FY(A-B+) AND FY(A+B-) FROM RETENTION CRRID, LOT ID100. THE PATIENT'S SAMPLES WERE NONREACTIVE IN ALL TESTING. THE RETURNED SAMPLES WERE TESTED IN HEMAGGLUTINATION TESTS WITH SELECTED FY(A+B+), FY(A-B+) AND FY(A+B-) FROM RETENTION PANOCELL-20, LOT 13600, USING IMMUADD AS THE POTENTIATOR. THE SAMPLES EXHIBITED MICROSCOPIC REACTIVITY WITH FY((A+B-) AND FY(A+B+) REAGENT RED CELLS. THE EVENTS APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A PATIENT SAMPLE CONTAINING ANTI-FYA ON THE ECHO WITH CAPTURE-R READY SCREEN (3) AND CAPTURE-R READY ID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R022

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR