BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYB

    MDR report key: 2458972 · Received February 17, 2012

    Report

    Report Number
    1034569-2012-00023
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    January 20, 2012
    Report Date
    February 17, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IN-HOUSE TESTING CONFIRMED THE REACTIVITY OF RETENTION ANTI-FYB, LOT 613012, BY TESTING THE ANTISERA WITH FOUR FY(A+B+) RED CELLS FROM RETENTION PANOCELL-20, LOT 52423, ALONG WITH THREE FY(A+B-) AND ONE FY(A-B-) RED CELLS FROM RETENTION PANOCELL-10, LOT 49377. THE DONORS FOR THE FY(A+B-) REAGENT RED CELLS HAVE DONATED GREATER THAN FOUR TIMES AT IMMUCOR. ALL RED BLOOD CELLS RESULTED APPROPRIATELY FOR THEIR RESPECTIVE FY(B) ANTIGEN TYPE. ALL RETENTION PRODUCTS PERFORMED AS EXPECTED. NO SAMPLE OR PRODUCT WAS RETURNED FROM THE CUSTOMER FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS WITH ANTI-FYB ANTISERA, LOT #613012 WHEN TESTING DONOR SAMPLE. THE DONOR HAS BEEN PREVIOUSLY TESTED ASFYB NEGATIVE 3 TIMES PRIOR TO THIS WITH DIFFERENT LOTS OF ANTI-FYB ANTISERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYB BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 613012

    Patients

    Seq Age Sex Outcome Treatment
    1