BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYB

    MDR report key: 1818710 · Received August 27, 2010

    Report

    Report Number
    1034569-2010-00190
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 27, 2010
    Manufacturer
    IMMUCOR
    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

    CONFIRMED THE REACTIVITY OF ANTI-FYB, LOTS 613004, 613005, 613006 AND 613008 BY TESTING THE ANTISERA WITH FOUR FY(A+B+) AND FOUR FY(B-) REAGENT RED CELLS FROM RETENTION PANOCELL-20. PERFORMED HEMAGGLUTINATION TESTS WITH CUSTOMER SUBMITTED SAMPLES 1 AND 2 WITH RETENTION ANTI-FYB, LOTS 613004, 613005, 613006 AND 613008. CONTROLS PERFORMED AS EXPECTED. THE SAMPLES EXHIBITED POSITIVE REACTIVITY (2+) WITH ALL ANTI-FYB ANTISERA. PERFORMED CAPTURE-R CROSSMATCHED ASSAY WITH SUBMITTED SAMPLES 1 AND 2 ON IN HOUSE ECHO WITH RETENTION CAPTURE-R SELECT, LOT SC0149, WITH THE SAME LOTS OF ANTI-FYB TESTED IN HEMAGGLUTINATION TESTS. CONTROLS PERFORMED AS EXPECTED AND THE SUBMITTED SAMPLES EXHIBITED POSITIVE REACTIVITY(4+) CONSISTENT WITH THE RESULTS OF TUBE HEMAGGLUTINATION TEST.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY ARE GETTING UNEXPECTED REACTIONS WHEN TESTING DONOR SAMPLES WITH ANTI-FYB, LOT 613005. CUSTOMER RECEIVED DISCREPANT RESULTS ON FOUR DONOR SAMPLES WITH ANTI-FYB. THE FOUR DONOR SAMPLES RESULTED NEGATIVE UPON INITIAL TESTING WITH ANTI-FYB, REPEAT TESTING RESULTED POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYB BLOOD GROUPING REAGENT KSZ IMMUCOR 613005

    Patients

    Seq Age Sex Outcome Treatment
    1