BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 853268 · Received May 18, 2007

    Report

    Report Number
    1034569-2007-00123
    Event Type
    Malfunction
    Date Received
    May 18, 2007
    Date of Event
    April 20, 2007
    Report Date
    May 18, 2007
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENCE OF THE FYA ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY-SCREEN, LOT W133. CUSTOMER SENT SAMPLES FOR INVESTIGATION TESTING. THE SAMPLES WERE TESTED ON AN IN-HOUSE GALILEO WITH RETENTION CAPTURE-R READY-SCREEN, LOTS W133 AND K125 USING RETENTION CAPTURE-R READY INDICATOR RED CELLS, LOT 221003. BOTH SAMPLES DEMONSTRATED POSITIVE REACTIVITY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS FOR ANTIBODY SCREEN WHEN TESTING A SPECIMEN CONTAINING ANTI-FYA USING CAPTURE-R INDICATOR RED CELLS, LOT 221996.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY INDICATOR RED CELLS KSZ IMMUCOR 221996

    Patients

    Seq Age Sex Outcome Treatment
    1 YR