BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN

    MDR report key: 1005598 · Received March 5, 2008

    Report

    Report Number
    1034569-2008-00053
    Event Type
    Malfunction
    Date Received
    March 5, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 29, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIRMED THE PRESENCE OF THE K ANTIGEN ON RETENTION CAPTURE-R READY-ID, LOT ID094, AND CAPTURE-R READY-SCREEN (I AND II), LOTS X225 AND X231, USING CAPTURE-R INDICATOR RED CELLS, LOT 221129. 2_CELL TESTING WAS PERFORMED ON AN IN-HOUSE GALILEO WITH CUSTOMER'S RETURNED PATIENTS' SAMPLES USING RETENTION CAPTURE-R READY-SCREEN (I AND II), LOTS X225 AND X231, AND CAPTURE-R INDICATOR RED CELLS, LOT 221129. BOTH SAMPLES EXHIBITED 2+ REACTIVITY WITH K+ CELL II ON CRRS (I AND II), LOT X225. ONE SAMPLE EXHIBITED 2+ REACTIVITY WITH K+ CELL I ON CRRS (I AND II), LOT X231. ONE SAMPLE WAS NONREACTIVE WITH K+ CELL I ON CRRS (I AND II), LOT X231. BOTH SAMPLES WERE NONREACTIVE WITH K NEGATIVE CELLS. THE NONREACTIVE SAMPLE WAS RETESTED TWO ADDITIONAL TIMES AND DEMONSTRATED 2+ REACTIVITY WITH CELL I ONCE AND WAS NEGATIVE IN THE SECOND TEST. THE EVENT APPEARS RELATED TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON THE 2_CELL SCREEN ASSAY WITH CRRS LOT X225 ON THE GALILEO. THIS PRENATAL SAMPLE IS HISTORICALLY KNOWN TO CONTAIN ANTI-K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. 221129

    Patients

    Seq Age Sex Outcome Treatment
    1