BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (POOLED) TEST WELLS

    MDR report key: 1066473 · Received July 1, 2008

    Report

    Report Number
    1034569-2008-00219
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 25, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S RETURNED SAMPLES WERE TESTED WITH RETENTION CAPTURE-R READY SCREEN POOLED LOT CW138, SINCE LOT CW 136 EXPIRED. THE SAMPLE THOGHT TO CONTAIN ANTI-K SHOWED WEAK REACTIVITY AND THE OTHER SAMPLE WAS NEGATIVE. THE SAMPLES WERE TESTED WITH CAPTURE-R READY ID LOT ID070. THE SAMPLE THOUGHT TO CONTAIN ANTI-K SHOWED WEAK ANTI-K ANTIBODY; THE OTHER SAMPLE WAS NEGATIVE. THE PACKAGE INSERT STATES: "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." THE EVENT APPEARS RELATED TO THE NATURE OF THE SAMPLES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY SCREEN (POOLE) WITH PATIENT SAMPLES KNOWN TO CONTAIN ANTI-K AND ANTI-FYA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN (POOLED) TEST WELLS REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. CW 136

    Patients

    Seq Age Sex Outcome Treatment
    1