BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYA

    MDR report key: 943080 · Received April 18, 2007

    Report

    Report Number
    1034569-2007-00080
    Event Type
    Malfunction
    Date Received
    April 18, 2007
    Date of Event
    March 20, 2007
    Report Date
    April 18, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REPEAT TESTING WITH ARC ANTI-FYA AND ORTHO ANTI-FYA RESULTED IN POSITIVE REACTIONS. REPEAT TESTING WITH A SECOND VIAL OF ANTI-FYA, LOT FYA62-1 RESULTED IN THE EXPECTED POSITIVE REACTIVITY. THE CUSTOMER REPORTED THAT THE REAGENT PERFORMED AS EXPECTED USING A NEW VIAL OF THE SAME LOT. PRODUCT WAS NOT RETURNED FROM CUSTOMER FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THEY ARE GETTING UNEXPECTED NEGATIVE REACTIONS WITH ANTI-FYA WHEN TESTING DONOR RED BLOOD CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYA BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. * FYA62H-1

    Patients

    Seq Age Sex Outcome Treatment
    1 *