BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3 TEST WELLS

    MDR report key: 1022986 · Received April 3, 2008

    Report

    Report Number
    1034569-2008-00086
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 21, 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 FYA AND C ANTIGENS ON RETENTION CAPTURE-R READY-SCREEN (3) LOT R021. CUSTOMER'S RETURNED PATIENT SAMPLES WERE TESTED WITH RETENTION CAPTURE-R READY-SCREEN (3), LOT R021, AND CAPTURE-R INDICATOR RED CELLS, LOT 221144. BOTH SAMPLES WERE NONREACTIVE WITH ALL CELLS. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH CUSTOMER'S SAMPLES USING SELECTED CELLS FROM PANOCELL-20, LOT 04478. IMMUADD WAS USED AS POTENTIATOR. THE SAMPLE REPORTED TO CONTAIN ANTI-FYA EXHIBITED VERY WEAK TO WEAK MICROSCOPIC REACTIVITY WITH FY(A+) CELLS AT IAT AND WAS NONREACTIVE WITH FY(A-) CELL. THE SAMPLE REPORTED TO CONTAIN ANTI-C EXHIBITED 2+S REACTIVITY AT 15'37C AND 2+ REACTIVITY AT IAT WITH C+C- CELL, AND VERY WEAK MICROSCOPIC REACTIVITY WITH C+C+ CELL AT IAT. THE NATURE OF THE SAMPLES CANNOT BE RULED OUT AS CAUSING THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER PERFORMED A PARALLEL STUDY COMPARING CAPTURE-R READY-SCREEN 3 TO SAMPLES TESTED BY THEIR CURRENT GEL METHOD. TWO SAMPLES, ONE CONTAINING ANTI-FYA AND ONE CONTAINING ANTI-C, DID NOT REACT IN MANUAL CAPTURE TESTING. THESE SAMPLES WERE TESTED BY TUBE METHOD WITH PANOSCREEN I,II, III, LOT 02461USING ORTHO LISS AS THE POTENTITATOR, REACTIVITY WAS SEEN WITH BOTH SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN 3 TEST WELLS REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R021

    Patients

    Seq Age Sex Outcome Treatment
    1