BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYA

    MDR report key: 763820 · Received August 4, 2006

    Report

    Report Number
    1034569-2006-00081
    Event Type
    Malfunction
    Date Received
    August 4, 2006
    Date of Event
    July 18, 2006
    Report Date
    August 4, 2006
    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

    TESTED RETENTION ANTI-FYA, LOT FYA61H-1 WITH FOUR FY (A+B+) AND FOUR FY (A-B+) REAGENT RED CELLS. EXPECTED REACTIVITY WAS OBSERVED. RETENTION PRODUCTS PERFORMED AS EXPECTED. SAMPLE WAS NOT RETURNED FROM CUSTOMER FOR INVESTIGATION. CUSTOMER STATES THEY HAVE VALIDATED ANTIGEN TYPING USING IMMUCOR ANTISERA WITH GEL TESTING AND HAVE BEEN USING THIS METHOD FOR THE PAST 5 YEARS. THE PACKAGE INSERT; HOWEVER, INSTRUCTS THE USER TO PERFORM TESTING USING THE TUBE METHOD. THE PACKAGE INSERT FURTHER WARNS THE USER THE FALSE RESULTS ARE POSSIBLE IF THERE ARE DEVIATIONS FROM RECOMMENDED TEST PROCEDURE. THE EVENT IS MOST LIKELY THE RESULT OF USER ERROR. THERE IS THE POTENTIAL TO TRANSFUSE INCOMPATIBLE BLOOD IF THE EVENT WAS TO RECUR.

    Description of Event or Problem · 1

    CUSTOMER REPORTS UNEXPECTED NEGATIVE REACTIONS WHEN TESTING FYA POSITIVE CELLS WITH ANTI-FYA, LOT FYA61H-1. TESTING IS PERFORMED USING THE GEL METHOD. PARALLEL TESTING WAS PERFORMED USING EXPIRED ORTHO ANTI-FYA AND THE INDATE IMMUCOR ANTI-FYA ANTISERA, LOT FYA61H-1. ORTHO REAGENT RESULTS WERE POSITIVE (2+); IMMUCOR REAGENT RESULTS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYA BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. * FYA61H-1

    Patients

    Seq Age Sex Outcome Treatment
    1 * EXP 07/21/2006| ORTHO PANEL CELLS, LOT 8RA197,