BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYA

    MDR report key: 4610668 · Received March 17, 2015

    Report

    Report Number
    1034569-2015-00043
    Event Type
    Malfunction
    Date Received
    March 17, 2015
    Date of Event
    February 18, 2015
    Report Date
    March 17, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR IN-HOUSE TESTING ON RETENTION PRODUCT CONFIRMED THE REACTIVITY OF ANTI-FYA, LOT 607019, IN TUBE, USING PANOCELL-20, LOT 51872. CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. POSITIVE REACTIVITY EXHIBITED REACTIONS OF 1+ AND 2+. WE WERE UNABLE TO RULE OUT THAT CUSTOMER'S VIAL MAY HAVE BECOME COMPROMISED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIVITY WITH DONOR UNITS WHEN USING BLOOD GROUPING REAGENT ANTI-FYA, LOT 607019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180910 ANTI-FYA BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 607019

    Patients

    Seq Age Sex Outcome Treatment
    1