BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN (POOLED CELLS)

    MDR report key: 1369718 · Received April 29, 2009

    Report

    Report Number
    1034569-2009-00143
    Event Type
    Malfunction
    Date Received
    April 29, 2009
    Date of Event
    April 3, 2009
    Report Date
    April 24, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE D ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN (POOLED CELLS), LOT N194 WITH RETENTION CAPTURE-R READY INDICATOR CELLS(CRRIC), LOT 221348. EXPECTED RESULTS WERE OBTAINED. THE CUSTOMER SUBMITTED SAMPLE FOR TESTING. SAMPLE COULD NOT BE TESTED DUE TO GROSS HEMOLYSIS PRESENT. THE LIMITATIONS SECTION OF THE PACKAGE INSERT FOR CAPTURE-R READY-SCREEN (POOLED CELLS) STATES THAT ANTIBODY TESTING USING POOLED REAGENT RED BLOOD CELLS WILL NOT BE AS SENSITIVE AS THOSE INCORPORTING THE RED BLOOD CELLS OF UNPOOLED SINGLE DONORS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREEN REACTIONS WITH POOL CELL TESTING ON THE GALILEO. A DONOR SAMPLE TESTED AS NEGATIVE BUT WAS POSITIVE IN GEL WITH TESTING WITH UNPOOLED CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN (POOLED CELLS) REAGENT RED BLOOD CELLS KSZ IMMUCOR N194

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR