BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (POOLED)

    MDR report key: 2960529 · Received February 14, 2013

    Report

    Report Number
    1034569-2013-00032
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    December 18, 2012
    Report Date
    February 13, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL REVIEW OF THE RESULT FILES ON THE NEO SHOWED THAT REACTIONS APPEARED AS REPORTED BY THE INSTRUMENT. THE CUSTOMER WAS REFERRED TO THE LIMITATION SECTION OF THE PACKAGE INSERT WHICH STATES THAT ANTIBODY SCREENING TESTS EMPLOYING POOLED REAGENT RED BLOOD CELLS WILL NOT BE AS SENSITIVE AS THOSE INCORPORATING THE RED BLOOD CELLS OF UNPOOLED SINGLE DONORS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIVITY WAS OBTAINED WITH CAPTURE-R READY-SCREEN (POOLED) TEST WELLS FOR A DONOR SAMPLE WITH A HISTORY OF HAVING ANTI-E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64524 CAPTURE-R READY-SCREEN (POOLED) REAGENT RED BLOOD CELL KSZ IMMUCOR, INC. N332

    Patients

    Seq Age Sex Outcome Treatment
    1