BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYB

    MDR report key: 823695 · Received February 1, 2007

    Report

    Report Number
    1034569-2007-00025
    Event Type
    Malfunction
    Date Received
    February 1, 2007
    Date of Event
    January 4, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUBMITTED PRODUCT FOR INVESTIGATION TESTING. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH RETURNED AND RETENTION ANTI-FYB, LOT FYB66H-1 USING FY(A+B+), FY (A+B-) AND FY(A-B+W) RED CELLS. ALL PRODUCTS PERFORMED AS EXPECTED. THE FY(B+W) CELL EXHIBITED W+ REACTIVITY WITH RETURNED PRODUCT AND 1+REACTIVITY WITH RETENTION PRODUCT. ALL FY(A-B+) CELLS EXHIBITED 2+ TO 2+S REACTIVITY AND ALL FY(B-) CELLS WERE NONREACTIVE WITH BOTH RETURNED AND RETENTION ANTI-FYB.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH ANTI-FYB, WHEN TESTING WITH CELL #1 (HETEROZYGOUS FYB CELL), OF PANOCELL 10, LOT 38462. REPEAT TESTING WITH CELL #4 (HETEROZYGOUS FYB CELL) OF PANOCELL 16, LOT 39467 ALSO RESULTED IN NEGATIVE REACTIONS. REPEAT TESTING WAS PERFORMED USING ORTHO ANTI-FYB AND RESULTED IN NEGATIVE REACTIONS WITH PANOCELL 10 CELL #1, AND 2+ REACTIVITY WITH PANOCELL 16 CELL #4. METHODOLOGY IS TUBE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYB BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. * FYB66H-1

    Patients

    Seq Age Sex Outcome Treatment
    1 *