BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 1241295 · Received November 25, 2008

    Report

    Report Number
    1034569-2008-00577
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 24, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE E AND K ANTIGENS WERE CONFIRMED ON RETURNED AND RETENTION CAPTURE-R READY ID (CRRID), LOT ID107, AND CAPTURE-R READY SCREEN (CRRS) 3 LOT R032, USING RETENTION CAPTURE- READY INDICATOR CELLS LOT 221269.THESE PRODUCTS WERE USED BY THE CUSTOMER AT THE TIME OF THE EVENT. THE CUSTOMER'S SUBMITED SAMPLE WAS TESTED WITH E-E+;K+K+ AND E+E-;K-K+ REAGENT RED CELLS FROM RETENTION PANOSCREEN I AND II, LOT 36959, USING IMMUADD AS THE POTENTIATOR. A ROOM TEMPERATURE INCUBATION WAS INCLUDED. VERY WEAK REACTIVITY WAS OBSERVED WITH E-E+;K+K+ REAGENT RED CELLS AT THE ROOM TEMPERATURE AND 37C TEST PHASE AND MICROSCOPIC REACTIVITY AT THE INDIRECT ANTIGLOBULIN TEST PHASE. NO REACTIVITY WAS OBSERVED WITH E+E- REAGENT RED CELLS IN ALL PHASES OF TESTING. THE SAMPLE WAS TESTED WITH SELECTED CELLS OF THE RETURNED AND RETENTION CRRS(3), LOT R032 AND RETENTION CRRID, LOT ID107 IN MANUAL SOLID PHASE TEST. THE SAMPLE WAS NONREACTIVE WITH ALL CELLS TESTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A PATIENT SAMPLE CONTAINING ANTI-E AND ANTI-K WITH MANUAL CAPTURE. ALL E AND K CELLS RESULTED NEGATIVE. NO TRANSFUSIONS OR ADVERSE REACTIONS OCCURRED AS A RESULT OF THE UNEXPECTED NEGATIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R032

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR